Clinical Neurology News

Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.

Photodisc/Thinkstock

During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.

Tonya hesitated.

“When might be a better time?”

Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.

“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.

The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
 

A ‘horrifying’ trend

Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.

Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”

Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.

It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
 

Physicians might be the most important lifeline

Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.

“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”

Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
 

COVID-19 as a weapon of abuse

Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.

“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.

Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.

This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.

“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.

Trust your clinical gut

How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?

Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.

If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.

Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.

The starting point of screening and intervention is to recognize that any domestic violence situation is potentially explosive. “The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.

“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.

Begin by asking if it is a convenient time to talk.

“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.

If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
 

‘Are you alone?’

Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.

“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.

For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.

It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.

Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”

The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
 

Technology is a double-edged sword

Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.

Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.

At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.

But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
 

Follow the patient’s lead

Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”

Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.

“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.

If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.

“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
 

What if the patient doesn’t want to get help?

If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.

Providing written information about how to get help is important but can be problematic if the abuser finds it.

Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.

“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
 

Resources are available during COVID-19

All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.

Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.

The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.

“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.

A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.

“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
 

‘Thinking on your feet’ critical for physicians

Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.

Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
 

Resources

National Domestic Violence Hotline

• 800-799-SAFE (7233)
• The patient can also text LOVEIS to 22522.

National Center on Domestic Violence, Trauma, and Mental Health

• Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
• Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
• Provides support for parents, caregivers, and children during the pandemic.
• Provides resources for advocates serving families affected by domestic violence.

U.S. Department of Justice

• A state-by-state guide to local resources

Children’s Hospital of Philadelphia Research Institute

STOP Intimate Partner Violence (IPV)
 

New Jersey Coalition for Domestic Violence

American Bar Association COVID-19 resources for communities

Crisis Text Line

• Text HOME to 741741.

National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety

A version of this article originally appeared on Medscape.com.

Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.

Photodisc/Thinkstock

During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.

Tonya hesitated.

“When might be a better time?”

Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.

“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.

The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
 

A ‘horrifying’ trend

Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.

Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”

Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.

It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
 

Physicians might be the most important lifeline

Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.

“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”

Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
 

COVID-19 as a weapon of abuse

Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.

“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.

Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.

This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.

“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.

Trust your clinical gut

How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?

Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.

If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.

Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.

The starting point of screening and intervention is to recognize that any domestic violence situation is potentially explosive. “The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.

“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.

Begin by asking if it is a convenient time to talk.

“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.

If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
 

‘Are you alone?’

Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.

“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.

For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.

It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.

Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”

The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
 

Technology is a double-edged sword

Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.

Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.

At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.

But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
 

Follow the patient’s lead

Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”

Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.

“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.

If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.

“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
 

What if the patient doesn’t want to get help?

If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.

Providing written information about how to get help is important but can be problematic if the abuser finds it.

Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.

“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
 

Resources are available during COVID-19

All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.

Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.

The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.

“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.

A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.

“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
 

‘Thinking on your feet’ critical for physicians

Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.

Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
 

Resources

National Domestic Violence Hotline

• 800-799-SAFE (7233)
• The patient can also text LOVEIS to 22522.

National Center on Domestic Violence, Trauma, and Mental Health

• Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
• Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
• Provides support for parents, caregivers, and children during the pandemic.
• Provides resources for advocates serving families affected by domestic violence.

U.S. Department of Justice

• A state-by-state guide to local resources

Children’s Hospital of Philadelphia Research Institute

STOP Intimate Partner Violence (IPV)
 

New Jersey Coalition for Domestic Violence

American Bar Association COVID-19 resources for communities

Crisis Text Line

• Text HOME to 741741.

National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety

A version of this article originally appeared on Medscape.com.

Roger R., MD, a primary care physician from Philadelphia, set up a telemedicine appointment with a 24-year-old female patient who was experiencing headaches and was worried she might have COVID-19.

Photodisc/Thinkstock

During the televisit, Dr. R. noticed that “Tonya” (not her real name) had a purplish bruise under her right eye. When asked how she got the bruise, Tonya said she had bumped into a dresser. The physician suspected abuse. He then heard a man’s voice in the background and thought it might belong to the abuser. “Is this a good time for you to talk?” he asked Tonya.

Tonya hesitated.

“When might be a better time?”

Tonya suggested an alternate time, and the physician called her then. During the visit, she shared that her fiancé, a car salesman who was also sheltering at home, was punching her.

“He always had a bad temper. Once he shoved me, but he’s never hit me before. And when he was upset, we used to go out to eat and he calmed down. Now, we’re stuck inside, we can’t even get away from each other to go to work, and he’s getting scary,” she told the doctor.

The physician asked if she would like to be connected with a domestic violence counselor. When Tonya agreed, he called Jessica DuBois Palardy, a licensed social worker and the program supervisor at STOP Intimate Partner Violence, a Philadelphia-based collaborative project of the Children’s Hospital of Philadelphia and the Lutheran Settlement House’s Bilingual Domestic Violence Program.
 

A ‘horrifying’ trend

Tonya’s story is not unique. A United Nations report shows that there has been a “horrifying global surge in domestic violence” linked to “lockdowns imposed by the governments responding to the COVID-19 pandemic.” The United States is no exception – 2,345 calls were placed to the National Domestic Violence Hotline during March 16–April 6, 2020.

Carole Warshaw, MD, director of the National Center on Domestic Violence, Trauma, and Mental Health in Chicago, said, “We know that intimate partner violence is increasing among people sheltering at home, and that abuse has become more severe.”

Even in nonabusive situations, being confined together at close quarters, often amid family stress and financial hardship, can be wearing, and tempers can flare. In an abusive relationship, “the main contributor to violence during shelter-in-place restrictions is that the isolation gives abusers more opportunities for controlling their partners, who have fewer options for accessing safety and support,” Dr. Warshaw said.

It is critical to “approach every clinical encounter knowing that domestic violence may be at play,” she emphasized.
 

Physicians might be the most important lifeline

Physicians are already facing myriad COVID-19–related challenges, and having another concern to keep in mind may be daunting.

“We’re in uncharted territory and we’re all trying to figure out how to navigate this time, how to practice medicine via phone and video conferences, and how to deal with the financial repercussions of the pandemic – not to mention concern for the health of our families,” said Peter F. Cronholm, MD, associate professor of family medicine and community health at the Hospital of the University of Pennsylvania, Philadelphia. “So maintaining vigilance is often difficult. Nevertheless, it’s important not to let this critical issue fall to the wayside.”

Marcella Nyachogo, MSW, a licensed social worker and assistant director of the Bilingual Domestic Violence Program, noted that physicians and other health care providers “may be the only people the patient interacts with, since the abuser may cut the survivor off from family and friends. And because the survivor isn’t leaving the house, he or she doesn’t have an opportunity to interact with coworkers or others – which makes health care providers the most important lifeline.”
 

COVID-19 as a weapon of abuse

Carey Watson, MD, regional medical director of the Family Violence Prevention Program at Kaiser Permanente in northern California, points to a disturbing trend in COVID-19–related abuse.

“Unfortunately, I’m hearing more and more accounts of how the illness itself can be one more weapon in the abuser’s arsenal,” she said.

Experts say that increasingly, abusers are claiming that their partner, who is employed in an “essential” job outside the home, is carrying the virus, and they are using this as a means of control and manipulation.

This is especially true of abusive partners of health care providers, Dr. Watson noted. She recounted the story of a divorced nurse whose husband did not allow her to have contact with their children, allegedly out of concern that she might have COVID-19, and would threaten her with a gun when she protested.

“It is important to keep this abusive tactic in mind, not only when dealing with patients but also with fellow physicians and health care professionals, and check in to see if everything is okay – especially if they seem particularly stressed out or distant,” Dr. Watson recommended.

Trust your clinical gut

How can you tell if your patients might be experiencing abuse when you’re not seeing them in person?

Pay attention to subtle signals and “trust your clinical gut when something doesn’t feel right,” Ms. Nyachogo advised.

If a patient’s demeanor is jittery or anxious or if someone next to him or her is answering all the questions or interrupting the visit, these could be red flags.

Dr. Cronholm added that telemedicine visits offer a “rare window into a patient’s home life that would not be available in an office visit.” For example, a house in disarray, the presence of broken objects, or the presence of another person hovering in the background suggests the need for further exploration.

The starting point of screening and intervention is to recognize that any domestic violence situation is potentially explosive. “The main thing for all providers to keep in mind is ‘first, do no harm,’ ” Ms. Nyachogo emphasized.

“Our agency has been working for years with medical professionals in how to screen and connect folks with help most effectively and safely, and – although the specific situations posed by COVID are new – the overall approach is the same, which is to proceed with caution in how you approach the subject and how you make referrals,” she said.

Begin by asking if it is a convenient time to talk.

“This question takes the onus off the patient, who may not know how to communicate that she has no privacy or is in the middle of an argument,” explained Elsa Swenson, program manager of Home Free community program, which serves individuals experiencing domestic violence. The program is part of Minnesota-based Missions Inc. Programs, which serves those experiencing domestic abuse and chemical dependency.

If the patient indicates that it isn’t a convenient time to talk, find out when would be a better time. “This might be difficult for busy physicians and may not be what they’re accustomed to when calling a patient at home, but the patient’s circumstances are unknown to you, so it’s essential to organize around their ability to talk,” Ms. Swenson noted.
 

‘Are you alone?’

Another important piece of information is whether the patient has privacy – which can be tricky if the abuser is standing right there.

“You don’t want to tip the abuser off to your concerns, so you need to frame the question in a neutral way,” Dr. Watson advised.

For example, you might say that HIPAA laws require that you conduct the consultation with no one else present, and find out if there is a location in the house where the patient can have privacy.

It might be easier to talk on the phone than via video, suggests Florence Remes, a New Jersey–based licensed social worker who specializes in domestic violence. Going into another room and playing music or turning on the television might make it less obvious that a call is taking place, and the abuser would be less likely to overhear the caller’s conversation.

Dr. Watson suggested that questions about abuse might be included with other questions and asked in a simple yes/no format. “I’d like to ask you some standard questions I’m asking everyone during the pandemic. Do you have a cough or fever? Do you have any other physical symptoms? Do you have access to hand sanitizer? How is your sleep? Are you experiencing stress? Do you feel safe at home?”

The abuser, if present, will only hear the patient’s “yes” or “no” without knowing the question. If the patient indicates that she is being abused but is unable to talk, a later time can be arranged to further explore the issue.
 

Technology is a double-edged sword

Modern technologies have been a great boon to patients and physicians during this time of social distancing, allowing ongoing contact and health care when it would not otherwise have been possible. On the other hand, technology is fraught with potential dangers that can jeopardize the patient’s safety and compromise privacy.

Ms. Remes recounted the story of “Susan,” a client with whom she had been conducting teletherapy visits using an approved HIPAA-compliant telemedicine forum. Susan was working from home because of shelter-in-place restrictions. Her husband had been abusive, and Susan was concerned he might be “sabotaging” the household’s WiFi to isolate her from outside sources of support.

At the recommendation of Ms. Remes, Susan continued sessions either via phone calls or by using the WhatsApp program on her cellphone. Many of the requirements governing HIPAA privacy regulations have been temporarily relaxed, and clinicians can use non–encrypted forms of transmission, such as FaceTime, WhatsApp, or Skype, if no other platform is available.

But even cellphones have risks, Dr. Warshaw noted. The patient’s abuser might track texts or look at call logs – especially on unsecured platforms. It’s advisable to ask patients about who has access to their phone and computer and discuss ways to increase security.
 

Follow the patient’s lead

Proceed slowly and start with nonthreatening questions, Ms. Palardy advised. “I notice you have some injuries; can you tell me how you got them? Did someone hurt you? What does your relationship look like when you argue? Is there anything that makes you feel uncomfortable or unsafe?”

Emphasizing that you are asking these questions because of care and concern is reassuring and helps patients to feel they are not alone, Ms. Nyachogo pointed out.

“As your doctor, I’m worried about your health and (if relevant) your children’s safety. I can help connect you with counseling and support, legal resources, and a shelter, and everything is free and confidential. Would you be interested?” she said.

If the client acknowledges abuse, “follow their lead, but don’t push too hard,” Ms. Nyachogo warned.

“It is the client’s choice whether or not to take action,” she noted. “I’ve met survivors who said that it wasn’t until a doctor or nurse expressed concern about bruises that it even occurred to them that they were being abused. Some lied to the doctor about how they got hurt – but the question planted a seed, even though it might have taken years to follow up on the referral,” she said.
 

What if the patient doesn’t want to get help?

If a patient is not ready to seek help, you can create a home-safety plan. This might include setting follow-up times. If you don’t hear from him or her, you should then call the police. Or you might create a “code word,” such as “apple pie.” If the patient uses that word during a session, you know her life is in danger, Ms. Remes suggested.

Providing written information about how to get help is important but can be problematic if the abuser finds it.

Ms. Nyachogo recommends e-mailing follow-up materials that cover a variety of topics, such as keeping safe during the COVID-19 pandemic, relaxation, healthy eating, getting exercise while homebound, activities for children, and suggestions for hotlines and other resources if one is feeling suicidal or unsafe.

“If you present these as your ‘standard’ follow-up materials, the abuser is less likely to become suspicious,” Ms. Nyachogo noted.
 

Resources are available during COVID-19

All of the experts emphasize that resources for victims of domestic violence remain available during the COVID-19 pandemic, although some shelters may be operating at reduced capacity. Some agencies are finding alternatives to group shelters, such as hotels or Airbnb, which carry less risk of catching COVID-19.

Referring a patient to domestic violence resources is a delicate process. “You don’t want referring the patient for help to further endanger their life,” Ms. Nyachogo said.

The more you can take the burden off the patient, the better. If she is interested in getting help, you can call a domestic violence counselor or advocate while she is on the phone.

“This type of ‘warm handoff’ is what Tonya’s physician did,” Ms. Palardy recounted.

A warm handoff requires that physicians be familiar with domestic violence resources, Dr. Warshaw emphasized.

“Don’t wait until you are working with someone who needs help to find out where to refer them. Take the time to proactively research local agencies specializing in domestic violence and have their phone numbers on hand, so you can offer resources immediately if the person is interested,” she advised. The National Domestic Violence Hotline can also assist with safety planning and access to local resources.
 

‘Thinking on your feet’ critical for physicians

Addressing domestic violence during this unprecedented time requires “thinking on your feet” about novel forms of detection and intervention, Dr. Watson said. This involves a combination of clinical acumen, creativity, and finely honed intuition.

Ms. Nyachogo added, “Keeping an eye on domestic violence can feel like an extra burden, but don’t forget that it is lifesaving work.”
 

Resources

National Domestic Violence Hotline

• 800-799-SAFE (7233)
• The patient can also text LOVEIS to 22522.

National Center on Domestic Violence, Trauma, and Mental Health

• Provides resources for health care, mental health, and substance use treatment and recovery support providers on responding to domestic violence and other trauma.
• Provides resources for professionals and patients regarding access to substance use and mental health care during the COVID-1 pandemic.
• Provides support for parents, caregivers, and children during the pandemic.
• Provides resources for advocates serving families affected by domestic violence.

U.S. Department of Justice

• A state-by-state guide to local resources

Children’s Hospital of Philadelphia Research Institute

STOP Intimate Partner Violence (IPV)
 

New Jersey Coalition for Domestic Violence

American Bar Association COVID-19 resources for communities

Crisis Text Line

• Text HOME to 741741.

National Network to End Domestic Violence (NNEDV) COVID-19 Technology Safety

A version of this article originally appeared on Medscape.com.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

Clinicians and pregnant women are less likely to prescribe and undergo the oral glucose tolerance test (OGTT) to diagnose gestational diabetes in the context of the COVID-19 pandemic, according to a review by H. David McIntyre, MD, of the University of Queensland, Brisbane, Australia, and Robert G. Moses, MD, of Wollongong (Australia) Hospital.

National and international discussions of whether a one- or two-step test for gestational diabetes mellitus (GDM) is optimal, and which women should be tested are ongoing, but the potential for exposure risks to COVID-19 are impacting the test process, they wrote in a commentary published in Diabetes Care.

“Any national or local guidelines should be developed with the primary aim of being protective for pregnant women and workable in the current health crisis,” they wrote.

Key concerns expressed by women and health care providers include the need for travel to be tested, the possible need for two visits, and the several hours spent in a potentially high-risk specimen collection center.

“Further, a GDM diagnosis generally involves additional health service visits for diabetes education, glucose monitoring review, and fetal ultrasonography, all of which carry exposure risks during a pandemic,” Dr. McIntyre and Dr. Moses noted.

Professional societies in the United Kingdom, Canada, and Australia have issued guidance to clinicians for modifying GDM diagnoses criteria during the pandemic that aim to reduce the need for the oral glucose tolerance test both during and after pregnancy.

Pandemic guidelines for all three of these countries support the identification of GDM using early pregnancy hemoglobin A_1c (HbA_1c) of at least 41 mmol/mol (5.9%).

Then, professionals in the United Kingdom recommend testing based on risk factors and diagnosing GDM based on any of these criteria: HbA_1c of at least 39 mmol/mol (5.7%), fasting venous plasma glucose of at least 5.6 mmol/L (preferred), or random VPG of at least 9.0 mmol/L.

The revised testing pathway for Canada accepts an HbA_1c of at least 39 mmol/mol (5.7%) and/or random VPG of at least 11.1 mmol/L.

“The revised Australian pathway does not include HbA_1c but recommends a fasting VPG with progression to OGTT only if this result is 4.7-5.0 mmol/L,” Dr. McIntyre and Dr. Moses explained.

Overall, the revised guidelines for GDM testing will likely miss some women and only identify those with higher levels of hyperglycemia, the authors wrote. In addition, “the evidence base for these revised pathways is limited and that each alternative strategy should be evaluated over the course of the current pandemic.”

Validation of new testing strategies are needed, and the pandemic may provide and opportunity to adopt an alternative to the OGTT. The World Health Organization has not issued revised guidance for other methods of testing, but fasting VPG alone may be the simplest and most cost effective, at least for the short term, they noted.

“In this ‘new COVID world,’ GDM should not be ignored but pragmatically merits a lower priority than the avoidance of exposure to the COVID-19 virus,” although no single alternative strategy applies in all countries and situations, the authors concluded. Pragmatic measures and documentation of outcomes at the local level will offer the “least worst” solution while the pandemic continues.

The authors had no relevant financial disclosures.

SOURCE: McIntyre HD, Moses RG. Diabetes Care. 2020 May. doi: 10.2337/dci20-0026.

You can catch COVID-19 if an infected person coughs or sneezes and contagious droplets enter your nose or mouth. But can you become ill if the virus lands in your eyes?

Virologist Joseph Fair, PhD, an NBC News contributor, raised that concern when he became critically ill with COVID-19, the disease caused by the coronavirus. From a hospital bed in his hometown of New Orleans, he told the network that he had flown on a crowded plane where flight attendants weren’t wearing masks. He wore a mask and gloves, but no eye protection.

“My best guess,” he told the interviewer, “was that it came through the eye route.”

Asked if people should start wearing eye protection, Dr. Fair replied, “In my opinion, yes.”

While Dr. Fair is convinced that eye protection helps, other experts aren’t sure. So much remains unknown about the new coronavirus, SARS-CoV-2, that researchers are still trying to establish whether infection can actually happen through the eyes.

“I don’t think we can answer that question with 100% confidence at this time,” said H. Nida Sen, MD, director of the uveitis clinic at the National Eye Institute in Bethesda, Md., and a clinical investigator who is studying the effects of COVID-19 on the eye. But, she says, “I think it is biologically plausible.”

Some research has begun pointing in that direction, according to Elia Duh, MD, a researcher and professor of ophthalmology at Johns Hopkins University in Baltimore.

The clear tissue that covers the white of the eye and lines the inside of the eyelid, known as the conjunctiva, “can be infected by other viruses, such as adenoviruses associated with the common cold and the herpes simplex virus,” he said.

There’s the same chance of infection with SARS-CoV-2, said Dr. Duh. “If there are droplets that an infected individual is producing by coughing or sneezing or even speaking, then the front of the eyes are directly exposed, just like the nasal passages are exposed. In addition, people rub and touch their eyes a lot. So there’s certainly already the vulnerability.”

To study whether SARS-CoV-2 could infect the eyes, Dr. Duh and fellow researchers at Johns Hopkins looked at whether the eye’s surface cells possess key factors that make the virus more likely to enter and infect them.

In their study (BioRxiv. 2020 May 9. doi: 10.1101/2020.05.09.086165), which is now being peer-reviewed, the team examined 10 postmortem eyes and five surgical samples of conjunctiva from patients who did not have the coronavirus. They wanted to see whether the eyes’ surface cells produced the key receptor for coronavirus, the ACE2 receptor.

For SARS-CoV-2 to enter a cell, “the cell has to have ACE2 on its surface so that the coronavirus can latch onto it and gain entry into the cell,” Dr. Duh said.

Not much research existed on ACE2 and the eye’s surface cells, he said. “We were really struck that ACE2 was clearly present in the surface cells of all of the specimens.” In addition, the researchers found that the eye’s surface cells also produce TMPRSS2, an enzyme that helps the virus enter the cell.

More research is needed for a definitive answer, Dr. Duh said. But “all of this evidence together seems to suggest that there’s a good likelihood that the ocular surface cells are susceptible to infection by coronavirus.”

If that’s the case, the virus then could be transmitted through the tear ducts that connect the eyes to the nasal cavity and subsequently infect the respiratory cells, he said.

Edward E. Manche, MD, professor of ophthalmology at Stanford (Calif.) University, said that while doctors don’t know for sure, many think eye infection can happen. “I think it’s widely believed now that you can acquire it through the eye. The way the virus works, it’s most commonly transmitted through the mouth and nasal passages. We have mucosal tissues where it can get in.”

Dr. Manche said the eyes would be “the least common mode of transmission.”

Besides looking at the eyes as an entryway, researchers are exploring whether people with SARS-CoV-2 in their eyes could infect others through their tears or eye secretions.

“The virus has been detected in tears and conjunctival swab specimens from individuals with COVID-19,” Dr. Duh said. “If someone rubs their eyes and then touches someone else or touches a surface, that kind of transmission mechanism could occur.

“It again highlights how contagious the coronavirus is and how stealthy it can be in its contagiousness,” he said.

If it turns out that the coronavirus can infect the eyes, the virus could persist there as a source of contagion, Dr. Duh said. “The eyes and tears could serve as a source of infection to others for longer.” He noted a case of a COVID-infected woman with conjunctivitis who still had detectable virus in her eyes 3 weeks after her symptoms started.

Conjunctivitis, commonly called pink eye, could be a symptom of COVID-19, said Dr. Sen, who is an ophthalmologist. She recommends that people get tested for COVID-19 if they have this condition, which is marked by redness, itchiness, tearing, discharge, and a gritty sensation in the eye.

Dr. Fair, the virologist, was released from the hospital to recover at home and continued to urge eye protection. “People like to call people like me fearmongers ... but the reality is, we’re just trying to keep them safe,” he told NBC News.

The CDC hasn’t issued such advice. In an email, the agency said it “does not have specific recommendations for the public regarding eye protection. However, in health care settings, the CDC does recommend eye protection for health care workers to prevent transmission via droplets.”

Dr. Sen agrees. “For the general public, I don’t think we have enough data to suggest that they should be covering the eyes in some form,” she said.

When she goes to the grocery store, she doesn’t wear eye protection. “I am only wearing goggles when I’m seeing ophthalmology patients up close, basically because I’m 4 or 5 inches away from them.”

But fuller protection – a mask, gloves, and even eye protection, such as goggles – might help those taking care of a COVID-19 patient at home, Dr. Manche said. “If you’re caring for somebody, that’s a much higher risk because they’re shedding viral load. You lessen the chance of transmission.”

For the public, Dr. Sen stresses the continued importance of hand hygiene. “In an abundance of caution, I would still encourage handwashing and not touching the eye for many reasons, not just COVID. You can transmit simple infections to your eye. We have other viruses and bacteria that are circulating in the environment and in our bodies elsewhere, so we can easily carry those to the eyes.”

Switching from contact lenses to eyeglasses could help cut down on touching the eyes, she says. Eyeglasses can also be a “mechanical barrier” to keep hands away.

Eyeglasses might block some droplets if someone nearby sneezes or coughs, Dr. Manche said, although they “aren’t sealed around the edges. They’re not like true medical goggles that are going to keep out the virus.”

Dr. Duh agrees that health care workers must don eye protection, but he said the public doesn’t need to start wearing goggles, face shields, or other eye protection. “I still think the major mode of transmission is through the nasal passages and the respiratory system,” he said.

It’s unclear whether eye protection is warranted for airplane passengers, Dr. Manche said. “It probably wouldn’t hurt, but I think the more important thing would be to take precautions: wearing a face mask, washing your hands, cleaning the seats and tray tables in front of you, and not touching things and touching your face and eyes.”

A version of this article originally appeared on WebMD.com.

You can catch COVID-19 if an infected person coughs or sneezes and contagious droplets enter your nose or mouth. But can you become ill if the virus lands in your eyes?

Virologist Joseph Fair, PhD, an NBC News contributor, raised that concern when he became critically ill with COVID-19, the disease caused by the coronavirus. From a hospital bed in his hometown of New Orleans, he told the network that he had flown on a crowded plane where flight attendants weren’t wearing masks. He wore a mask and gloves, but no eye protection.

“My best guess,” he told the interviewer, “was that it came through the eye route.”

Asked if people should start wearing eye protection, Dr. Fair replied, “In my opinion, yes.”

While Dr. Fair is convinced that eye protection helps, other experts aren’t sure. So much remains unknown about the new coronavirus, SARS-CoV-2, that researchers are still trying to establish whether infection can actually happen through the eyes.

“I don’t think we can answer that question with 100% confidence at this time,” said H. Nida Sen, MD, director of the uveitis clinic at the National Eye Institute in Bethesda, Md., and a clinical investigator who is studying the effects of COVID-19 on the eye. But, she says, “I think it is biologically plausible.”

Some research has begun pointing in that direction, according to Elia Duh, MD, a researcher and professor of ophthalmology at Johns Hopkins University in Baltimore.

The clear tissue that covers the white of the eye and lines the inside of the eyelid, known as the conjunctiva, “can be infected by other viruses, such as adenoviruses associated with the common cold and the herpes simplex virus,” he said.

There’s the same chance of infection with SARS-CoV-2, said Dr. Duh. “If there are droplets that an infected individual is producing by coughing or sneezing or even speaking, then the front of the eyes are directly exposed, just like the nasal passages are exposed. In addition, people rub and touch their eyes a lot. So there’s certainly already the vulnerability.”

To study whether SARS-CoV-2 could infect the eyes, Dr. Duh and fellow researchers at Johns Hopkins looked at whether the eye’s surface cells possess key factors that make the virus more likely to enter and infect them.

In their study (BioRxiv. 2020 May 9. doi: 10.1101/2020.05.09.086165), which is now being peer-reviewed, the team examined 10 postmortem eyes and five surgical samples of conjunctiva from patients who did not have the coronavirus. They wanted to see whether the eyes’ surface cells produced the key receptor for coronavirus, the ACE2 receptor.

For SARS-CoV-2 to enter a cell, “the cell has to have ACE2 on its surface so that the coronavirus can latch onto it and gain entry into the cell,” Dr. Duh said.

Not much research existed on ACE2 and the eye’s surface cells, he said. “We were really struck that ACE2 was clearly present in the surface cells of all of the specimens.” In addition, the researchers found that the eye’s surface cells also produce TMPRSS2, an enzyme that helps the virus enter the cell.

More research is needed for a definitive answer, Dr. Duh said. But “all of this evidence together seems to suggest that there’s a good likelihood that the ocular surface cells are susceptible to infection by coronavirus.”

If that’s the case, the virus then could be transmitted through the tear ducts that connect the eyes to the nasal cavity and subsequently infect the respiratory cells, he said.

Edward E. Manche, MD, professor of ophthalmology at Stanford (Calif.) University, said that while doctors don’t know for sure, many think eye infection can happen. “I think it’s widely believed now that you can acquire it through the eye. The way the virus works, it’s most commonly transmitted through the mouth and nasal passages. We have mucosal tissues where it can get in.”

Dr. Manche said the eyes would be “the least common mode of transmission.”

Besides looking at the eyes as an entryway, researchers are exploring whether people with SARS-CoV-2 in their eyes could infect others through their tears or eye secretions.

“The virus has been detected in tears and conjunctival swab specimens from individuals with COVID-19,” Dr. Duh said. “If someone rubs their eyes and then touches someone else or touches a surface, that kind of transmission mechanism could occur.

“It again highlights how contagious the coronavirus is and how stealthy it can be in its contagiousness,” he said.

If it turns out that the coronavirus can infect the eyes, the virus could persist there as a source of contagion, Dr. Duh said. “The eyes and tears could serve as a source of infection to others for longer.” He noted a case of a COVID-infected woman with conjunctivitis who still had detectable virus in her eyes 3 weeks after her symptoms started.

Conjunctivitis, commonly called pink eye, could be a symptom of COVID-19, said Dr. Sen, who is an ophthalmologist. She recommends that people get tested for COVID-19 if they have this condition, which is marked by redness, itchiness, tearing, discharge, and a gritty sensation in the eye.

Dr. Fair, the virologist, was released from the hospital to recover at home and continued to urge eye protection. “People like to call people like me fearmongers ... but the reality is, we’re just trying to keep them safe,” he told NBC News.

The CDC hasn’t issued such advice. In an email, the agency said it “does not have specific recommendations for the public regarding eye protection. However, in health care settings, the CDC does recommend eye protection for health care workers to prevent transmission via droplets.”

Dr. Sen agrees. “For the general public, I don’t think we have enough data to suggest that they should be covering the eyes in some form,” she said.

When she goes to the grocery store, she doesn’t wear eye protection. “I am only wearing goggles when I’m seeing ophthalmology patients up close, basically because I’m 4 or 5 inches away from them.”

But fuller protection – a mask, gloves, and even eye protection, such as goggles – might help those taking care of a COVID-19 patient at home, Dr. Manche said. “If you’re caring for somebody, that’s a much higher risk because they’re shedding viral load. You lessen the chance of transmission.”

For the public, Dr. Sen stresses the continued importance of hand hygiene. “In an abundance of caution, I would still encourage handwashing and not touching the eye for many reasons, not just COVID. You can transmit simple infections to your eye. We have other viruses and bacteria that are circulating in the environment and in our bodies elsewhere, so we can easily carry those to the eyes.”

Switching from contact lenses to eyeglasses could help cut down on touching the eyes, she says. Eyeglasses can also be a “mechanical barrier” to keep hands away.

Eyeglasses might block some droplets if someone nearby sneezes or coughs, Dr. Manche said, although they “aren’t sealed around the edges. They’re not like true medical goggles that are going to keep out the virus.”

Dr. Duh agrees that health care workers must don eye protection, but he said the public doesn’t need to start wearing goggles, face shields, or other eye protection. “I still think the major mode of transmission is through the nasal passages and the respiratory system,” he said.

It’s unclear whether eye protection is warranted for airplane passengers, Dr. Manche said. “It probably wouldn’t hurt, but I think the more important thing would be to take precautions: wearing a face mask, washing your hands, cleaning the seats and tray tables in front of you, and not touching things and touching your face and eyes.”

A version of this article originally appeared on WebMD.com.

You can catch COVID-19 if an infected person coughs or sneezes and contagious droplets enter your nose or mouth. But can you become ill if the virus lands in your eyes?

Virologist Joseph Fair, PhD, an NBC News contributor, raised that concern when he became critically ill with COVID-19, the disease caused by the coronavirus. From a hospital bed in his hometown of New Orleans, he told the network that he had flown on a crowded plane where flight attendants weren’t wearing masks. He wore a mask and gloves, but no eye protection.

“My best guess,” he told the interviewer, “was that it came through the eye route.”

Asked if people should start wearing eye protection, Dr. Fair replied, “In my opinion, yes.”

While Dr. Fair is convinced that eye protection helps, other experts aren’t sure. So much remains unknown about the new coronavirus, SARS-CoV-2, that researchers are still trying to establish whether infection can actually happen through the eyes.

“I don’t think we can answer that question with 100% confidence at this time,” said H. Nida Sen, MD, director of the uveitis clinic at the National Eye Institute in Bethesda, Md., and a clinical investigator who is studying the effects of COVID-19 on the eye. But, she says, “I think it is biologically plausible.”

Some research has begun pointing in that direction, according to Elia Duh, MD, a researcher and professor of ophthalmology at Johns Hopkins University in Baltimore.

The clear tissue that covers the white of the eye and lines the inside of the eyelid, known as the conjunctiva, “can be infected by other viruses, such as adenoviruses associated with the common cold and the herpes simplex virus,” he said.

There’s the same chance of infection with SARS-CoV-2, said Dr. Duh. “If there are droplets that an infected individual is producing by coughing or sneezing or even speaking, then the front of the eyes are directly exposed, just like the nasal passages are exposed. In addition, people rub and touch their eyes a lot. So there’s certainly already the vulnerability.”

To study whether SARS-CoV-2 could infect the eyes, Dr. Duh and fellow researchers at Johns Hopkins looked at whether the eye’s surface cells possess key factors that make the virus more likely to enter and infect them.

In their study (BioRxiv. 2020 May 9. doi: 10.1101/2020.05.09.086165), which is now being peer-reviewed, the team examined 10 postmortem eyes and five surgical samples of conjunctiva from patients who did not have the coronavirus. They wanted to see whether the eyes’ surface cells produced the key receptor for coronavirus, the ACE2 receptor.

For SARS-CoV-2 to enter a cell, “the cell has to have ACE2 on its surface so that the coronavirus can latch onto it and gain entry into the cell,” Dr. Duh said.

Not much research existed on ACE2 and the eye’s surface cells, he said. “We were really struck that ACE2 was clearly present in the surface cells of all of the specimens.” In addition, the researchers found that the eye’s surface cells also produce TMPRSS2, an enzyme that helps the virus enter the cell.

More research is needed for a definitive answer, Dr. Duh said. But “all of this evidence together seems to suggest that there’s a good likelihood that the ocular surface cells are susceptible to infection by coronavirus.”

If that’s the case, the virus then could be transmitted through the tear ducts that connect the eyes to the nasal cavity and subsequently infect the respiratory cells, he said.

Edward E. Manche, MD, professor of ophthalmology at Stanford (Calif.) University, said that while doctors don’t know for sure, many think eye infection can happen. “I think it’s widely believed now that you can acquire it through the eye. The way the virus works, it’s most commonly transmitted through the mouth and nasal passages. We have mucosal tissues where it can get in.”

Dr. Manche said the eyes would be “the least common mode of transmission.”

Besides looking at the eyes as an entryway, researchers are exploring whether people with SARS-CoV-2 in their eyes could infect others through their tears or eye secretions.

“The virus has been detected in tears and conjunctival swab specimens from individuals with COVID-19,” Dr. Duh said. “If someone rubs their eyes and then touches someone else or touches a surface, that kind of transmission mechanism could occur.

“It again highlights how contagious the coronavirus is and how stealthy it can be in its contagiousness,” he said.

If it turns out that the coronavirus can infect the eyes, the virus could persist there as a source of contagion, Dr. Duh said. “The eyes and tears could serve as a source of infection to others for longer.” He noted a case of a COVID-infected woman with conjunctivitis who still had detectable virus in her eyes 3 weeks after her symptoms started.

Conjunctivitis, commonly called pink eye, could be a symptom of COVID-19, said Dr. Sen, who is an ophthalmologist. She recommends that people get tested for COVID-19 if they have this condition, which is marked by redness, itchiness, tearing, discharge, and a gritty sensation in the eye.

Dr. Fair, the virologist, was released from the hospital to recover at home and continued to urge eye protection. “People like to call people like me fearmongers ... but the reality is, we’re just trying to keep them safe,” he told NBC News.

The CDC hasn’t issued such advice. In an email, the agency said it “does not have specific recommendations for the public regarding eye protection. However, in health care settings, the CDC does recommend eye protection for health care workers to prevent transmission via droplets.”

Dr. Sen agrees. “For the general public, I don’t think we have enough data to suggest that they should be covering the eyes in some form,” she said.

When she goes to the grocery store, she doesn’t wear eye protection. “I am only wearing goggles when I’m seeing ophthalmology patients up close, basically because I’m 4 or 5 inches away from them.”

But fuller protection – a mask, gloves, and even eye protection, such as goggles – might help those taking care of a COVID-19 patient at home, Dr. Manche said. “If you’re caring for somebody, that’s a much higher risk because they’re shedding viral load. You lessen the chance of transmission.”

For the public, Dr. Sen stresses the continued importance of hand hygiene. “In an abundance of caution, I would still encourage handwashing and not touching the eye for many reasons, not just COVID. You can transmit simple infections to your eye. We have other viruses and bacteria that are circulating in the environment and in our bodies elsewhere, so we can easily carry those to the eyes.”

Switching from contact lenses to eyeglasses could help cut down on touching the eyes, she says. Eyeglasses can also be a “mechanical barrier” to keep hands away.

Eyeglasses might block some droplets if someone nearby sneezes or coughs, Dr. Manche said, although they “aren’t sealed around the edges. They’re not like true medical goggles that are going to keep out the virus.”

Dr. Duh agrees that health care workers must don eye protection, but he said the public doesn’t need to start wearing goggles, face shields, or other eye protection. “I still think the major mode of transmission is through the nasal passages and the respiratory system,” he said.

It’s unclear whether eye protection is warranted for airplane passengers, Dr. Manche said. “It probably wouldn’t hurt, but I think the more important thing would be to take precautions: wearing a face mask, washing your hands, cleaning the seats and tray tables in front of you, and not touching things and touching your face and eyes.”

A version of this article originally appeared on WebMD.com.

Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.

Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.

“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.

The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.

“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.

Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).

Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.

“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.

Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.

Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.

Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”

The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).

Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.

Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.

The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.

Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.

Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.

A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).

Each of the two age groups accounted for 32% of the hospitalized patients.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.

Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.

“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.

The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.

“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.

Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).

Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.

“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.

Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.

Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.

Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”

The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).

Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.

Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.

The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.

Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.

Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.

A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).

Each of the two age groups accounted for 32% of the hospitalized patients.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest.

Jerry Y. Chao, MD, of the department of anesthesiology, Albert Einstein College of Medicine, New York, and colleagues reported their findings in an article published online May 11 in the Journal of Pediatrics.

“Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care,” senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children’s Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release.

The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children’s hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients.

“As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis,” the authors wrote.

Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU).

Almost one-third (14 children; 30.4%) of the admitted patients were obese, and almost one-quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission.

“We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit,” Dr. Chao said in the news release.

Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. “There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU,” the authors wrote.

Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.

Patients admitted to the PICU were more likely to need high-flow nasal cannula. Ten (77%) patients in the PICU developed acute respiratory distress syndrome (ARDS), and six (46.2%) of them needed “invasive mechanical ventilation for a median of 9 days.”

The only clinical symptom significantly linked to PICU admission was shortness of breath (92.3% vs 30.3%; P < .001).

Eight (61.5%) of the 13 patients treated in the PICU were discharged to home; four (30.7%) were still hospitalized and receiving ventilatory support on day 14. One patient had metastatic cancer and died as a result of the cancer after life-sustaining therapy was withdrawn.

Those admitted to the PICU were more likely to receive treatment with remdesivir via compassionate use compared with those treated in the general medical unit. Seven (53.8%) patients in the PICU developed severe sepsis and septic shock syndromes.

The average hospital stay was 4 days longer for the children admitted to the PICU than for the children admitted to the general medical unit.

Cough (63%) and fever (60.9%) were the most frequently reported symptoms at admission. The median duration of symptoms before admission was 3 days. None of the children had traveled to an area affected by COVID-19 before becoming ill, and only 20 (43.5%) children were confirmed to have had contact with someone with COVID-19. “The lack of a known sick contact reported in our study may have implications for how healthcare providers identify and screen for potential cases,” the authors explained.

Although children are believed to experience milder SARS-CoV-2 illness, these results and those of an earlier study suggest that some pediatric patients develop illness severe enough to require PICU admission. “This subset had significantly higher markers of inflammation (CRP, pro-BNP, procalcitonin) compared with patients in the medical unit. Inflammation likely contributed to the high rate of ARDS we observed, although serum levels of IL-6 and other cytokines linked to ARDS were not determined,” the authors wrote.

A retrospective cohort study found that of 177 children and young adults treated in a single center, patients younger than 1 year and older than 15 years were more likely to become critically ill with COVID-19 (J Pediatr. 2020 May. doi: 10.1016/j.jpeds.2020.05.007).

Each of the two age groups accounted for 32% of the hospitalized patients.

The authors have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

One of the greatest tragedies of the first wave of the COVID-19 pandemic has been the failure of health policy makers to anticipate and mitigate the enormous havoc the policy of social distancing would wreak on mental health and cognitive function in older persons, speakers agreed at a webinar on COVID-19, social distancing, and its impact on social and mental health in the elderly hosted by the International Psychogeriatric Association in collaboration with INTERDEM.

iofoto/Thinkstock

“Social distancing” is a two-edged sword: It is for now and the foreseeable future the only available effective strategy for protecting against infection in the older population most vulnerable to severe forms of COVID-19. Yet social distancing also has caused many elderly – particularly those in nursing homes and other long-term care facilities – to plunge into a profound experience of loneliness, isolation, distress, feelings of abandonment, anxiety, depression, and accelerated cognitive deterioration. And this needn’t have happened, the mental health professionals asserted.

“When are we going to get rid of the term ‘social distancing?’ ” asked IPA President William E. Reichman, MD. “Many have appreciated – including the World Health Organization – that the real issue is physical distancing to prevent contagion. And physical distancing doesn’t have to mean social distancing.”

Social connectedness between elderly persons and their peers and family members can be maintained and should be emphatically encouraged during the physical distancing required by the pandemic, said Myrra Vernooij-Dassen, PhD, of Radboud University in Nigmegen, the Netherlands, and chair of INTERDEM, a pan-European network of dementia researchers.

This can be achieved using readily available technologies, including the telephone and videoconferencing, as well as by creating opportunities for supervised masked visits between a family member and an elderly loved one in outdoor courtyards or gardens within long-term care facilities. And yet, as the pandemic seized hold in many parts of the world, family members were blocked from entry to these facilities, she observed.
 

Impact on mental health, cognition

Dr. Vernooij-Dassen noted that studies of previous quarantine periods as well as preliminary findings during the COVID-19 pandemic demonstrate an inverse relationship between social isolation measures and cognitive functioning in the elderly.

“A striking finding is that lack of social interaction is associated with incident dementia. Conversely, epidemiologic data indicate that a socially integrated lifestyle had a favorable influence on cognitive functioning and could even delay onset of dementia,” she said.

INTERDEM is backing two ongoing studies evaluating the hypothesis that interventions fostering increased social interaction among elderly individuals can delay onset of dementia or favorably affect its course. The proposed mechanism of benefit is stimulation of brain plasticity to enhance cognitive reserve.

“This is a hypothesis of hope. We know that social interaction for humans is like water to plants – we really, really need it,” she explained.

Diego de Leo, MD, PhD, emeritus professor of psychiatry and former director of the Australian Institute for Suicide Research and Prevention at Griffith University in Brisbane, was living in hard-hit Padua, Italy, during the first surge of COVID-19. He described his anecdotal experience.

“What I hear from many Italian colleagues and friends and directors of mental health services is that emergency admissions related to mental disorders declined during the first wave of the COVID pandemic. For example, not many people attended emergency departments due to suicide attempts; there was a very marked decrease in the number of suicide attempts during the worst days of the pandemic,” he said.

People with psychiatric conditions were afraid to go to the hospital because they thought they would contract the infection and die there. That’s changing now, however.

“Now there is an increased number of admissions to mental health units. A new wave. It has been a U-shaped curve. And we’re now witnessing an increasing number of fatal suicides due to persistent fears, due to people imagining that there is no more room for them, and no more future for them from a financial point of view – which is the major negative outcome of this crisis. It will be a disaster for many families,” the psychiatrist continued.

A noteworthy phenomenon in northern Italy was that, when tablets were made available to nursing home residents in an effort to enhance their connectedness to the outside world, those with dementia often became so frustrated and confused by their difficulty in using the devices that they developed a hypokinetic delirium marked by refusal to eat or leave their bed, he reported.

It’s far too early to have reliable data on suicide trends in response to the pandemic, according to Dr. de Leo. But one thing is for sure: The strategy of social distancing employed to curb COVID-19 has increased the prevalence of known risk factors for suicide in older individuals, including loneliness, anxiety, and depression; increased alcohol use; and a perception of being a burden on society. Dr. de Leo directs a foundation dedicated to helping people experiencing traumatic bereavement, and in one recent week, the foundation was contacted by eight families in the province of Padua with a recent death by suicide apparently related to fallout from the COVID-19 pandemic. That’s an unusually high spike in suicide in a province with a population of 1 million.

“People probably preferred to end the agitation, the fear, the extreme anxiety about their destiny by deciding to prematurely truncate their life. That has been reported by nursing staff,” he said.

The Italian government has determined that, to date, 36% of all COVID-related deaths have occurred in people aged 85 years or older, and 84% of deaths were in individuals aged at least 70 years. And in Milan and the surrounding province of Lombardy, it’s estimated that COVID-19 has taken the lives of 25% of all nursing home residents. The North American experience has been uncomfortably similar.

“Almost 80% of COVID deaths in Canada have occurred in congregate settings,” observed Dr. Reichman, professor of psychiatry at the University of Toronto, and president and CEO of Baycrest Health Sciences, a geriatric research center.

“Certainly, the appalling number of deaths in nursing homes is the No. 1 horror of the pandemic,” declared Carmelle Peisah, MBBS, MD, a psychiatrist at the University of New South Wales in Kensington, Australia.
 

The fire next time

The conventional wisdom holds that COVID-19 has caused all sorts of mayhem in the delivery of elder care. Not so, in Dr. Reichman’s view.

“I would suggest that the pandemic has not caused many of the problems we talk about, it’s actually revealed problems that have always been there under the surface. For example, many older people, even before COVID-19, were socially isolated, socially distant. They had difficulty connecting with their relatives, difficulty accessing transportation to get to the store to buy food and see their doctors, and to interact with other older people,” the psychiatrist said.

“I would say as well that the pandemic didn’t cause the problems we’ve seen in long-term congregate senior care. The pandemic revealed them. We’ve had facilities where older people were severely crowded together, which compromises their quality of life, even when there’s not a pandemic. We’ve had difficulty staffing these kinds of environments with people that are paid an honest wage for the very hard work that they do. In many of these settings they’re inadequately trained, not only in infection prevention and control but in all other aspects of care. And the pandemic has revealed that many of these organizations are not properly funded. The government doesn’t support them well enough across jurisdictions, and they can’t raise enough philanthropic funds to provide the kind of quality of life that residents demand,” Dr. Reichman continued.

Could the pandemic spur improved elder care? His hope is that health care professionals, politicians, and society at large will learn from the devastation left by the first surge of the pandemic and will lobby for the resources necessary for much-needed improvements in geriatric care.

“We need to be better prepared should there be not only a second wave of this pandemic, but for other pandemics to come,” Dr. Reichman concluded.

The speakers indicated they had no financial conflicts regarding their presentations.

[email protected]

Here are the stories our MDedge editors across specialties think you need to know about today:

Remdesivir trial data published

Weeks after topline remdesivir data appeared in the press, investigators published their full experience using the drug to treat COVID-19 patients. The study, published in the New England Journal of Medicine, showed the drug reduced recovery time from 15 to 11 days, compared with placebo. Patients receiving oxygen seemed to fare best from treatment with remdesivir. “There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.” READ MORE.

FDA approves contraceptive gel

The Food and Drug Administration approved Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent pregnancy in women of reproductive potential. It’s the first nonhormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the range of 3.5-4.5. READ MORE.

COVID-19 lessons from one cancer center

Physicians at Levine Cancer Institute in Charlotte, N.C., largely have been able to keep hematologic oncology patients on their treatment regimens and continue to care for inpatients during the early months of the COVID-19 pandemic. How have they kept the situation managable? Strict infection control, liberal testing, and a proactive plan to defer and temporarily replace infusion care when medically appropriate were all part of the strategy. “My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious, even before the coronavirus, using distancing, masking, and meticulous hand hygiene,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in Levine Cancer Institute’s Department of Hematologic Oncology and Blood Disorders. READ MORE.

Convalescent plasma: Hope or hype?

There are currently more than two dozen trials of convalescent plasma in the United States and elsewhere but most are single-arm trials to determine if one infusion can decrease the need for intubation or help patients on a ventilator to improve. Others researchers are investigating whether convalescent plasma might be used before severe disease sets in. Meanwhile, about 2,200 hospitals are participating in an expanded access program being led by the Mayo Clinic nationwide. The National Institutes of Health recently said that “there are insufficient clinical data to recommend either for or against” its use for COVID-19. READ MORE.

New rosacea treatment guidelines

Patients with rosacea should receive treatments based on their phenotype and specific symptoms, rather than being assigned into distinct subtype categories, according to updated guidance published in the Journal of the American Academy of Dermatology. The update comes from the National Rosacea Society Expert Committee and is based on a review of the evidence. Patients “shouldn’t be classified as having a certain subtype of rosacea” since “many patients have features that overlap more than one subtype,” said Diane Thiboutot, MD, lead author of the update and a professor of dermatology and associate dean of clinical and translational research education at Penn State University, Hershey. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Remdesivir trial data published

Weeks after topline remdesivir data appeared in the press, investigators published their full experience using the drug to treat COVID-19 patients. The study, published in the New England Journal of Medicine, showed the drug reduced recovery time from 15 to 11 days, compared with placebo. Patients receiving oxygen seemed to fare best from treatment with remdesivir. “There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.” READ MORE.

FDA approves contraceptive gel

The Food and Drug Administration approved Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent pregnancy in women of reproductive potential. It’s the first nonhormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the range of 3.5-4.5. READ MORE.

COVID-19 lessons from one cancer center

Physicians at Levine Cancer Institute in Charlotte, N.C., largely have been able to keep hematologic oncology patients on their treatment regimens and continue to care for inpatients during the early months of the COVID-19 pandemic. How have they kept the situation managable? Strict infection control, liberal testing, and a proactive plan to defer and temporarily replace infusion care when medically appropriate were all part of the strategy. “My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious, even before the coronavirus, using distancing, masking, and meticulous hand hygiene,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in Levine Cancer Institute’s Department of Hematologic Oncology and Blood Disorders. READ MORE.

Convalescent plasma: Hope or hype?

There are currently more than two dozen trials of convalescent plasma in the United States and elsewhere but most are single-arm trials to determine if one infusion can decrease the need for intubation or help patients on a ventilator to improve. Others researchers are investigating whether convalescent plasma might be used before severe disease sets in. Meanwhile, about 2,200 hospitals are participating in an expanded access program being led by the Mayo Clinic nationwide. The National Institutes of Health recently said that “there are insufficient clinical data to recommend either for or against” its use for COVID-19. READ MORE.

New rosacea treatment guidelines

Patients with rosacea should receive treatments based on their phenotype and specific symptoms, rather than being assigned into distinct subtype categories, according to updated guidance published in the Journal of the American Academy of Dermatology. The update comes from the National Rosacea Society Expert Committee and is based on a review of the evidence. Patients “shouldn’t be classified as having a certain subtype of rosacea” since “many patients have features that overlap more than one subtype,” said Diane Thiboutot, MD, lead author of the update and a professor of dermatology and associate dean of clinical and translational research education at Penn State University, Hershey. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Remdesivir trial data published

Weeks after topline remdesivir data appeared in the press, investigators published their full experience using the drug to treat COVID-19 patients. The study, published in the New England Journal of Medicine, showed the drug reduced recovery time from 15 to 11 days, compared with placebo. Patients receiving oxygen seemed to fare best from treatment with remdesivir. “There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.” READ MORE.

FDA approves contraceptive gel

The Food and Drug Administration approved Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel to prevent pregnancy in women of reproductive potential. It’s the first nonhormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the range of 3.5-4.5. READ MORE.

COVID-19 lessons from one cancer center

Physicians at Levine Cancer Institute in Charlotte, N.C., largely have been able to keep hematologic oncology patients on their treatment regimens and continue to care for inpatients during the early months of the COVID-19 pandemic. How have they kept the situation managable? Strict infection control, liberal testing, and a proactive plan to defer and temporarily replace infusion care when medically appropriate were all part of the strategy. “My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious, even before the coronavirus, using distancing, masking, and meticulous hand hygiene,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in Levine Cancer Institute’s Department of Hematologic Oncology and Blood Disorders. READ MORE.

Convalescent plasma: Hope or hype?

There are currently more than two dozen trials of convalescent plasma in the United States and elsewhere but most are single-arm trials to determine if one infusion can decrease the need for intubation or help patients on a ventilator to improve. Others researchers are investigating whether convalescent plasma might be used before severe disease sets in. Meanwhile, about 2,200 hospitals are participating in an expanded access program being led by the Mayo Clinic nationwide. The National Institutes of Health recently said that “there are insufficient clinical data to recommend either for or against” its use for COVID-19. READ MORE.

New rosacea treatment guidelines

Patients with rosacea should receive treatments based on their phenotype and specific symptoms, rather than being assigned into distinct subtype categories, according to updated guidance published in the Journal of the American Academy of Dermatology. The update comes from the National Rosacea Society Expert Committee and is based on a review of the evidence. Patients “shouldn’t be classified as having a certain subtype of rosacea” since “many patients have features that overlap more than one subtype,” said Diane Thiboutot, MD, lead author of the update and a professor of dermatology and associate dean of clinical and translational research education at Penn State University, Hershey. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Ignorance may be bliss for some. But as I sit here in my scenic social isolation on the Maine coast I find that, like most people, what I don’t know unsettles me. How is the COVID-19 virus spread? Does my wife’s wipe down of the doorknobs after I return from the grocery store really make us any less likely to contract the virus? Is wearing my homemade bandana face mask doing anything to protect me? I suspect not, but I wear it as a statement of courtesy and solidarity to my fellow community members.

zimmytws/Thinkstock

Does the 6-foot rule make any sense? I’ve read that it is based on a study dating back to the 1930s. I’ve seen images of the 25-foot droplet plume blasting out from a sneeze and understand that, as a bicyclist, I may be generating a shower of droplets in my wake. But, are those droplets a threat to anyone I pedal by if I am symptom free? What does being a carrier mean when we are talking about COVID-19?

What makes me more vulnerable to this particular virus as an apparently healthy septuagenarian? What collection of misfortunes have fallen on those younger victims of the pandemic? How often was it genetic?

Of course, none of us has the information yet that can provide us answers. This vacuum has attracted scores of “experts” bold enough or careless enough to venture an opinion. They may have also issued a caveat, but how often have the media failed to include it in the report or buried it in the fine print at the end of the story?

My discomfort with this information void has left me and you and everyone else to our imaginations to craft our own explanations. So, I try to piece together a construct based on what I can glean from what I read and see in the news because like most people I fortunately have no first-hand information about even a single case. The number of deaths is horrifying, but may not have hit close to home and given most of us a real personal sense of the illness and its character.

Maine is a small state with just over a million inhabitants, and most of us have some connection to one another. It may be that a person is the second cousin of someone who used to live 2 miles down the road. But, there is some feeling of familiarity. We have had deaths related to COVID-19, but very scanty information other than the county about where they occurred and whether the victim was a resident of an extended care facility. We are told very little if any details about exposure as officials invoke HIPAA regulations that leave us in the dark. Other than one vague reference to a “traveling salesman” who may have introduced the virus to several nursing homes, there has been very little information about how the virus may have been spread here in Maine. Even national reports of the deaths of high-profile entertainers and retired athletes are usually draped in the same haze of privacy.

Most of us don’t need to know the names and street addresses of the victims but a few anonymous narratives that include some general information on how epidemiologists believe clusters began and propagated would help us understand our risks with just a glimmer of clarity.

Of course the epidemiologists may not have the answers we are seeking because they too are struggling to untangle connections hampered by concerns of privacy. There is no question that privacy must remain an important part of the physician-patient relationship. But a pandemic has thrown us into a situation where common sense demands that HIPAA be interpreted with an emphasis on the greater good. Finding that balance between privacy and public knowledge will continue to be one of our greatest challenges.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Ignorance may be bliss for some. But as I sit here in my scenic social isolation on the Maine coast I find that, like most people, what I don’t know unsettles me. How is the COVID-19 virus spread? Does my wife’s wipe down of the doorknobs after I return from the grocery store really make us any less likely to contract the virus? Is wearing my homemade bandana face mask doing anything to protect me? I suspect not, but I wear it as a statement of courtesy and solidarity to my fellow community members.

zimmytws/Thinkstock

Does the 6-foot rule make any sense? I’ve read that it is based on a study dating back to the 1930s. I’ve seen images of the 25-foot droplet plume blasting out from a sneeze and understand that, as a bicyclist, I may be generating a shower of droplets in my wake. But, are those droplets a threat to anyone I pedal by if I am symptom free? What does being a carrier mean when we are talking about COVID-19?

What makes me more vulnerable to this particular virus as an apparently healthy septuagenarian? What collection of misfortunes have fallen on those younger victims of the pandemic? How often was it genetic?

Of course, none of us has the information yet that can provide us answers. This vacuum has attracted scores of “experts” bold enough or careless enough to venture an opinion. They may have also issued a caveat, but how often have the media failed to include it in the report or buried it in the fine print at the end of the story?

My discomfort with this information void has left me and you and everyone else to our imaginations to craft our own explanations. So, I try to piece together a construct based on what I can glean from what I read and see in the news because like most people I fortunately have no first-hand information about even a single case. The number of deaths is horrifying, but may not have hit close to home and given most of us a real personal sense of the illness and its character.

Maine is a small state with just over a million inhabitants, and most of us have some connection to one another. It may be that a person is the second cousin of someone who used to live 2 miles down the road. But, there is some feeling of familiarity. We have had deaths related to COVID-19, but very scanty information other than the county about where they occurred and whether the victim was a resident of an extended care facility. We are told very little if any details about exposure as officials invoke HIPAA regulations that leave us in the dark. Other than one vague reference to a “traveling salesman” who may have introduced the virus to several nursing homes, there has been very little information about how the virus may have been spread here in Maine. Even national reports of the deaths of high-profile entertainers and retired athletes are usually draped in the same haze of privacy.

Most of us don’t need to know the names and street addresses of the victims but a few anonymous narratives that include some general information on how epidemiologists believe clusters began and propagated would help us understand our risks with just a glimmer of clarity.

Of course the epidemiologists may not have the answers we are seeking because they too are struggling to untangle connections hampered by concerns of privacy. There is no question that privacy must remain an important part of the physician-patient relationship. But a pandemic has thrown us into a situation where common sense demands that HIPAA be interpreted with an emphasis on the greater good. Finding that balance between privacy and public knowledge will continue to be one of our greatest challenges.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Ignorance may be bliss for some. But as I sit here in my scenic social isolation on the Maine coast I find that, like most people, what I don’t know unsettles me. How is the COVID-19 virus spread? Does my wife’s wipe down of the doorknobs after I return from the grocery store really make us any less likely to contract the virus? Is wearing my homemade bandana face mask doing anything to protect me? I suspect not, but I wear it as a statement of courtesy and solidarity to my fellow community members.

zimmytws/Thinkstock

Does the 6-foot rule make any sense? I’ve read that it is based on a study dating back to the 1930s. I’ve seen images of the 25-foot droplet plume blasting out from a sneeze and understand that, as a bicyclist, I may be generating a shower of droplets in my wake. But, are those droplets a threat to anyone I pedal by if I am symptom free? What does being a carrier mean when we are talking about COVID-19?

What makes me more vulnerable to this particular virus as an apparently healthy septuagenarian? What collection of misfortunes have fallen on those younger victims of the pandemic? How often was it genetic?

Of course, none of us has the information yet that can provide us answers. This vacuum has attracted scores of “experts” bold enough or careless enough to venture an opinion. They may have also issued a caveat, but how often have the media failed to include it in the report or buried it in the fine print at the end of the story?

My discomfort with this information void has left me and you and everyone else to our imaginations to craft our own explanations. So, I try to piece together a construct based on what I can glean from what I read and see in the news because like most people I fortunately have no first-hand information about even a single case. The number of deaths is horrifying, but may not have hit close to home and given most of us a real personal sense of the illness and its character.

Maine is a small state with just over a million inhabitants, and most of us have some connection to one another. It may be that a person is the second cousin of someone who used to live 2 miles down the road. But, there is some feeling of familiarity. We have had deaths related to COVID-19, but very scanty information other than the county about where they occurred and whether the victim was a resident of an extended care facility. We are told very little if any details about exposure as officials invoke HIPAA regulations that leave us in the dark. Other than one vague reference to a “traveling salesman” who may have introduced the virus to several nursing homes, there has been very little information about how the virus may have been spread here in Maine. Even national reports of the deaths of high-profile entertainers and retired athletes are usually draped in the same haze of privacy.

Most of us don’t need to know the names and street addresses of the victims but a few anonymous narratives that include some general information on how epidemiologists believe clusters began and propagated would help us understand our risks with just a glimmer of clarity.

Of course the epidemiologists may not have the answers we are seeking because they too are struggling to untangle connections hampered by concerns of privacy. There is no question that privacy must remain an important part of the physician-patient relationship. But a pandemic has thrown us into a situation where common sense demands that HIPAA be interpreted with an emphasis on the greater good. Finding that balance between privacy and public knowledge will continue to be one of our greatest challenges.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Much-anticipated results from the National Institute of Allergy and Infectious Diseases’ clinical trial of remdesivir in COVID-19 patients published in the New England Journal of Medicine suggest remdesivir shortens the disease course for hospitalized COVID-19 patients.

The agency reported initial promising results from the study earlier this month, which prompted the Food and Drug Administration to issue an emergency use authorization (EUA) for the drug, but the full data and results have not been widely available until now.

In the study of 1,063 patients, the researchers found patients who received a 10-day course of remdesivir had a reduced recovery time of 11 days, compared with 15 days to recovery in the group that received a placebo. The findings also suggest remdesivir should be started, if possible, before patients have such severe pulmonary disease that they require mechanical ventilation, according to the study authors.

The published results are “completely consistent” with the NIAID’s earlier announcement, H. Clifford Lane, MD, deputy director for clinical research and special projects at the NIAID, said in an interview. “The benefit appeared to be the greatest for the patients who are hospitalized with severe disease who require supplemental oxygen.”

Given the limited supply of remdesivir, physicians have been eager to see the full data to ensure they use the drug most effectively, Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said in an interview. Hospitals in states across the country, including New York, Michigan, and Washington, have received limited supplies of the drug in the last couple of weeks since the FDA’s authorization.

“I am losing my patience waiting for #remdesivir data. I was willing to give them a week to verify the numbers, triple proof the tables, cautiously frame conclusions. But it’s gone on too long. We are rationing with no rationale. We are floating on whisps [sic] of data, adrift,” Kate Stephenson, MD, an infectious diseases specialist at the Center for Virology and Vaccine Research at Harvard Medical School, Boston, wrote on Twitter May 18. After reading the paper, she tweeted Friday evening that she was “relieved to see convincing benefit – I was starting to worry!”

In the midst of a public health crisis, however, it is not unusual to make an announcement about trial results before the full dataset has been analyzed, said Dr. Lane. The NIAID followed a similar playbook for the PALM trial evaluating possible Ebola treatments in the Democratic Republic of Congo, with the independent monitoring board recommending the trial be terminated early in response to positive results from two of the four candidate drugs.

“When you have a result you think is of public health importance, you don’t wait for it to be published in a peer-reviewed journal,” said Dr. Lane, a coauthor of the study. The lag time from announcement to study publication was a result of the time it took to write up the paper for publication and go through peer review, Dr. Lane added. He also noted that the FDA had access to the data when the agency wrote its guidance for physicians administering the drug to patients under the EUA.

The authors opted not to publish the initial findings on a preprint server because they felt it was important to undergo peer review, said Dr. Lane. “The last thing you want for something this critical is for incomplete data to be out there, or you don’t have everything audited to the level that you want.”

 

Trial details

In the ACTT-1 randomized, placebo-controlled, double-blinded trial, researchers enrolled 1,063 patients from Feb. 21 to April 19, 2020, at 60 trial sites and 13 subsites worldwide (45 sites in the United States). The remdesivir group had 541 patients, and the placebo group had 522. A small number of patients (49 in the remdesivir group and 53 in the placebo group) discontinued treatment before day 10 because of an adverse event or withdrawn consent. When data collection for this preliminary analysis ended in late April, 301 patients had not recovered and had not completed their final follow-up visit.

Most of the patients had one (27%) or more (52.1%) preexisting conditions, including hypertension (49.6%), obesity (37%), and type 2 diabetes mellitus (29.7%). Mean patient age was 58.9 years, and the majority of patients were men (64.3%). The median number of days from symptom onset to randomization was 9, and 53.6% of the patients were white, 20.6% were black, 12.6% were Asian, 23.4% were Hispanic or Latino, and the ethnicity of 13.6% were not reported or reported as other.

Patients received one 200-mg loading dose on the first day of the trial, and then one 100-mg maintenance dose every day for days 2 through 10, or until discharge or death. Patients in the control group of the study received a matching placebo on the same schedule and volume. The clinical status of each patient was assessed every day, from day 1 through day 29 of his or her hospital stay, according to an eight-category ordinal scale.

Time to recovery was defined as the first day during the 28-day enrollment period that a patient’s clinical status met a 1 (not hospitalization, no activity limitations), 2 (not hospitalized, activity limitation, oxygen requirement or both), or 3 (hospitalized, not requiring supplemental oxygen or medical care if hospitalization was extended for infection-control reasons) on the eight-category scale. A score of 4 indicated a patient was hospitalized and needed ongoing medical care, but did not require supplemental oxygen; a score of 8 signified death.

The analysis found remdesivir patients had a median time to recovery of 11 days, compared with the median 15 days for patients on the placebo (rate ratio for recovery, 1.32; 95% confidence interval, 1.12-1.55; P < .001). Mortality was also lower in the remdesivir group (hazard ratio for death, 0.70; 95% CI, 0.47-1.04), but the result was not statistically significant. By 14 days, the Kaplan-Meier estimate of mortality was 7.1 % in the remdesivir group and 11.9% in the placebo group.

Patients receiving oxygen, but not yet requiring high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation, seemed to fare best from treatment with remdesivir (these patients had a baseline ordinal score of 5). That may be a result of the larger sample size of these patients, the researchers note in the study. The study authors were unable to estimate the recovery time for the most severely ill patients (category 7), possibly because the follow-up time was too short to fully evaluate this subgroup.

“There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Dr. Kaul, who was not involved in the study, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.”

Dr. Kaul said there is still the possibility that remdesivir could benefit patients on mechanical ventilation, but “clinicians will have to determine if the evidence suggesting no benefit in those who are intubated is strong enough to justify using this currently scarce resource in that population versus limiting use to those requiring oxygen but not on mechanical ventilation.”

Site investigators estimated that just four serious adverse events (two in each group) in enrolled patients were related to remdesivir or placebo. No deaths were attributed to the treatments, although acute respiratory failure, hypotension, acute kidney injury, and viral pneumonia were slightly more common in patients receiving the placebo than those receiving remdesivir.

The researchers plan to publish a follow-up study in the coming weeks or months, after the full cohort has completed 28 days of follow-up, Dr. Lane said. In future studies, the agency will likely focus on comparing remdesivir with combinations of remdesivir with other treatments, like the anti-inflammatory baricitinib.

A version of this article originally appeared on Medscape.com.

Much-anticipated results from the National Institute of Allergy and Infectious Diseases’ clinical trial of remdesivir in COVID-19 patients published in the New England Journal of Medicine suggest remdesivir shortens the disease course for hospitalized COVID-19 patients.

The agency reported initial promising results from the study earlier this month, which prompted the Food and Drug Administration to issue an emergency use authorization (EUA) for the drug, but the full data and results have not been widely available until now.

In the study of 1,063 patients, the researchers found patients who received a 10-day course of remdesivir had a reduced recovery time of 11 days, compared with 15 days to recovery in the group that received a placebo. The findings also suggest remdesivir should be started, if possible, before patients have such severe pulmonary disease that they require mechanical ventilation, according to the study authors.

The published results are “completely consistent” with the NIAID’s earlier announcement, H. Clifford Lane, MD, deputy director for clinical research and special projects at the NIAID, said in an interview. “The benefit appeared to be the greatest for the patients who are hospitalized with severe disease who require supplemental oxygen.”

Given the limited supply of remdesivir, physicians have been eager to see the full data to ensure they use the drug most effectively, Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said in an interview. Hospitals in states across the country, including New York, Michigan, and Washington, have received limited supplies of the drug in the last couple of weeks since the FDA’s authorization.

“I am losing my patience waiting for #remdesivir data. I was willing to give them a week to verify the numbers, triple proof the tables, cautiously frame conclusions. But it’s gone on too long. We are rationing with no rationale. We are floating on whisps [sic] of data, adrift,” Kate Stephenson, MD, an infectious diseases specialist at the Center for Virology and Vaccine Research at Harvard Medical School, Boston, wrote on Twitter May 18. After reading the paper, she tweeted Friday evening that she was “relieved to see convincing benefit – I was starting to worry!”

In the midst of a public health crisis, however, it is not unusual to make an announcement about trial results before the full dataset has been analyzed, said Dr. Lane. The NIAID followed a similar playbook for the PALM trial evaluating possible Ebola treatments in the Democratic Republic of Congo, with the independent monitoring board recommending the trial be terminated early in response to positive results from two of the four candidate drugs.

“When you have a result you think is of public health importance, you don’t wait for it to be published in a peer-reviewed journal,” said Dr. Lane, a coauthor of the study. The lag time from announcement to study publication was a result of the time it took to write up the paper for publication and go through peer review, Dr. Lane added. He also noted that the FDA had access to the data when the agency wrote its guidance for physicians administering the drug to patients under the EUA.

The authors opted not to publish the initial findings on a preprint server because they felt it was important to undergo peer review, said Dr. Lane. “The last thing you want for something this critical is for incomplete data to be out there, or you don’t have everything audited to the level that you want.”

 

Trial details

In the ACTT-1 randomized, placebo-controlled, double-blinded trial, researchers enrolled 1,063 patients from Feb. 21 to April 19, 2020, at 60 trial sites and 13 subsites worldwide (45 sites in the United States). The remdesivir group had 541 patients, and the placebo group had 522. A small number of patients (49 in the remdesivir group and 53 in the placebo group) discontinued treatment before day 10 because of an adverse event or withdrawn consent. When data collection for this preliminary analysis ended in late April, 301 patients had not recovered and had not completed their final follow-up visit.

Most of the patients had one (27%) or more (52.1%) preexisting conditions, including hypertension (49.6%), obesity (37%), and type 2 diabetes mellitus (29.7%). Mean patient age was 58.9 years, and the majority of patients were men (64.3%). The median number of days from symptom onset to randomization was 9, and 53.6% of the patients were white, 20.6% were black, 12.6% were Asian, 23.4% were Hispanic or Latino, and the ethnicity of 13.6% were not reported or reported as other.

Patients received one 200-mg loading dose on the first day of the trial, and then one 100-mg maintenance dose every day for days 2 through 10, or until discharge or death. Patients in the control group of the study received a matching placebo on the same schedule and volume. The clinical status of each patient was assessed every day, from day 1 through day 29 of his or her hospital stay, according to an eight-category ordinal scale.

Time to recovery was defined as the first day during the 28-day enrollment period that a patient’s clinical status met a 1 (not hospitalization, no activity limitations), 2 (not hospitalized, activity limitation, oxygen requirement or both), or 3 (hospitalized, not requiring supplemental oxygen or medical care if hospitalization was extended for infection-control reasons) on the eight-category scale. A score of 4 indicated a patient was hospitalized and needed ongoing medical care, but did not require supplemental oxygen; a score of 8 signified death.

The analysis found remdesivir patients had a median time to recovery of 11 days, compared with the median 15 days for patients on the placebo (rate ratio for recovery, 1.32; 95% confidence interval, 1.12-1.55; P < .001). Mortality was also lower in the remdesivir group (hazard ratio for death, 0.70; 95% CI, 0.47-1.04), but the result was not statistically significant. By 14 days, the Kaplan-Meier estimate of mortality was 7.1 % in the remdesivir group and 11.9% in the placebo group.

Patients receiving oxygen, but not yet requiring high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation, seemed to fare best from treatment with remdesivir (these patients had a baseline ordinal score of 5). That may be a result of the larger sample size of these patients, the researchers note in the study. The study authors were unable to estimate the recovery time for the most severely ill patients (category 7), possibly because the follow-up time was too short to fully evaluate this subgroup.

“There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Dr. Kaul, who was not involved in the study, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.”

Dr. Kaul said there is still the possibility that remdesivir could benefit patients on mechanical ventilation, but “clinicians will have to determine if the evidence suggesting no benefit in those who are intubated is strong enough to justify using this currently scarce resource in that population versus limiting use to those requiring oxygen but not on mechanical ventilation.”

Site investigators estimated that just four serious adverse events (two in each group) in enrolled patients were related to remdesivir or placebo. No deaths were attributed to the treatments, although acute respiratory failure, hypotension, acute kidney injury, and viral pneumonia were slightly more common in patients receiving the placebo than those receiving remdesivir.

The researchers plan to publish a follow-up study in the coming weeks or months, after the full cohort has completed 28 days of follow-up, Dr. Lane said. In future studies, the agency will likely focus on comparing remdesivir with combinations of remdesivir with other treatments, like the anti-inflammatory baricitinib.

A version of this article originally appeared on Medscape.com.

Much-anticipated results from the National Institute of Allergy and Infectious Diseases’ clinical trial of remdesivir in COVID-19 patients published in the New England Journal of Medicine suggest remdesivir shortens the disease course for hospitalized COVID-19 patients.

The agency reported initial promising results from the study earlier this month, which prompted the Food and Drug Administration to issue an emergency use authorization (EUA) for the drug, but the full data and results have not been widely available until now.

In the study of 1,063 patients, the researchers found patients who received a 10-day course of remdesivir had a reduced recovery time of 11 days, compared with 15 days to recovery in the group that received a placebo. The findings also suggest remdesivir should be started, if possible, before patients have such severe pulmonary disease that they require mechanical ventilation, according to the study authors.

The published results are “completely consistent” with the NIAID’s earlier announcement, H. Clifford Lane, MD, deputy director for clinical research and special projects at the NIAID, said in an interview. “The benefit appeared to be the greatest for the patients who are hospitalized with severe disease who require supplemental oxygen.”

Given the limited supply of remdesivir, physicians have been eager to see the full data to ensure they use the drug most effectively, Daniel Kaul, MD, a professor of infectious diseases at the University of Michigan, Ann Arbor, said in an interview. Hospitals in states across the country, including New York, Michigan, and Washington, have received limited supplies of the drug in the last couple of weeks since the FDA’s authorization.

“I am losing my patience waiting for #remdesivir data. I was willing to give them a week to verify the numbers, triple proof the tables, cautiously frame conclusions. But it’s gone on too long. We are rationing with no rationale. We are floating on whisps [sic] of data, adrift,” Kate Stephenson, MD, an infectious diseases specialist at the Center for Virology and Vaccine Research at Harvard Medical School, Boston, wrote on Twitter May 18. After reading the paper, she tweeted Friday evening that she was “relieved to see convincing benefit – I was starting to worry!”

In the midst of a public health crisis, however, it is not unusual to make an announcement about trial results before the full dataset has been analyzed, said Dr. Lane. The NIAID followed a similar playbook for the PALM trial evaluating possible Ebola treatments in the Democratic Republic of Congo, with the independent monitoring board recommending the trial be terminated early in response to positive results from two of the four candidate drugs.

“When you have a result you think is of public health importance, you don’t wait for it to be published in a peer-reviewed journal,” said Dr. Lane, a coauthor of the study. The lag time from announcement to study publication was a result of the time it took to write up the paper for publication and go through peer review, Dr. Lane added. He also noted that the FDA had access to the data when the agency wrote its guidance for physicians administering the drug to patients under the EUA.

The authors opted not to publish the initial findings on a preprint server because they felt it was important to undergo peer review, said Dr. Lane. “The last thing you want for something this critical is for incomplete data to be out there, or you don’t have everything audited to the level that you want.”

 

Trial details

In the ACTT-1 randomized, placebo-controlled, double-blinded trial, researchers enrolled 1,063 patients from Feb. 21 to April 19, 2020, at 60 trial sites and 13 subsites worldwide (45 sites in the United States). The remdesivir group had 541 patients, and the placebo group had 522. A small number of patients (49 in the remdesivir group and 53 in the placebo group) discontinued treatment before day 10 because of an adverse event or withdrawn consent. When data collection for this preliminary analysis ended in late April, 301 patients had not recovered and had not completed their final follow-up visit.

Most of the patients had one (27%) or more (52.1%) preexisting conditions, including hypertension (49.6%), obesity (37%), and type 2 diabetes mellitus (29.7%). Mean patient age was 58.9 years, and the majority of patients were men (64.3%). The median number of days from symptom onset to randomization was 9, and 53.6% of the patients were white, 20.6% were black, 12.6% were Asian, 23.4% were Hispanic or Latino, and the ethnicity of 13.6% were not reported or reported as other.

Patients received one 200-mg loading dose on the first day of the trial, and then one 100-mg maintenance dose every day for days 2 through 10, or until discharge or death. Patients in the control group of the study received a matching placebo on the same schedule and volume. The clinical status of each patient was assessed every day, from day 1 through day 29 of his or her hospital stay, according to an eight-category ordinal scale.

Time to recovery was defined as the first day during the 28-day enrollment period that a patient’s clinical status met a 1 (not hospitalization, no activity limitations), 2 (not hospitalized, activity limitation, oxygen requirement or both), or 3 (hospitalized, not requiring supplemental oxygen or medical care if hospitalization was extended for infection-control reasons) on the eight-category scale. A score of 4 indicated a patient was hospitalized and needed ongoing medical care, but did not require supplemental oxygen; a score of 8 signified death.

The analysis found remdesivir patients had a median time to recovery of 11 days, compared with the median 15 days for patients on the placebo (rate ratio for recovery, 1.32; 95% confidence interval, 1.12-1.55; P < .001). Mortality was also lower in the remdesivir group (hazard ratio for death, 0.70; 95% CI, 0.47-1.04), but the result was not statistically significant. By 14 days, the Kaplan-Meier estimate of mortality was 7.1 % in the remdesivir group and 11.9% in the placebo group.

Patients receiving oxygen, but not yet requiring high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation, seemed to fare best from treatment with remdesivir (these patients had a baseline ordinal score of 5). That may be a result of the larger sample size of these patients, the researchers note in the study. The study authors were unable to estimate the recovery time for the most severely ill patients (category 7), possibly because the follow-up time was too short to fully evaluate this subgroup.

“There is clear and consistent evidence of clinically significant benefit for those hospitalized on oxygen but not yet requiring mechanical ventilation,” Dr. Kaul, who was not involved in the study, said after seeing the published results. “Surprisingly, early dosing as measured from time to onset of symptoms did not seem to make a difference.”

Dr. Kaul said there is still the possibility that remdesivir could benefit patients on mechanical ventilation, but “clinicians will have to determine if the evidence suggesting no benefit in those who are intubated is strong enough to justify using this currently scarce resource in that population versus limiting use to those requiring oxygen but not on mechanical ventilation.”

Site investigators estimated that just four serious adverse events (two in each group) in enrolled patients were related to remdesivir or placebo. No deaths were attributed to the treatments, although acute respiratory failure, hypotension, acute kidney injury, and viral pneumonia were slightly more common in patients receiving the placebo than those receiving remdesivir.

The researchers plan to publish a follow-up study in the coming weeks or months, after the full cohort has completed 28 days of follow-up, Dr. Lane said. In future studies, the agency will likely focus on comparing remdesivir with combinations of remdesivir with other treatments, like the anti-inflammatory baricitinib.

A version of this article originally appeared on Medscape.com.

Real epidemiologists are out knocking on doors, chasing down contacts, or hunched over their computers trying to make sense out of screens full of data and maps. A few are trying valiantly to talk some sense into our elected officials.

konradlew/Thinkstock

This leaves the rest of us with time on our hands to fabricate our own less-than-scientific explanations for the behavior of the SARS-CoV-2 virus. So I have decided to put on hold my current mental challenge of choosing which pasta shape to pair with the sauce I’ve prepared from an online recipe. Here is my educated guess based on what I can glean from media sources that may have been filtered through a variety politically biased lenses. Remember, I did go to medical school; however, when I was in college the DNA helix was still just theoretical.

From those halcyon days of mid-February when our attention was focused on the Diamond Princess quarantined in Yokohama Harbor, it didn’t take a board-certified epidemiologist to suspect that the virus was spreading through the ventilating system in the ship’s tight quarters. Subsequent outbreaks on U.S. and French military ships suggests a similar explanation.

While still not proven, it sounds like SARS-CoV-2 jumped to humans from bats. It should not surprise us that having evolved in a dense population of mammals it would thrive in other high-density populations such as New York and nursing homes. Because we have lacked a robust testing capability, it has been less obvious until recently that, while it is easily transmitted, the virus has infected many who are asymptomatic (“Antibody surveys suggesting vast undercount of coronavirus infections may be unreliable,” Gretchen Vogel, Science, April 21, 2020). Subsequent surveys seem to confirm this higher level carrier state; it suggests that the virus is far less deadly than was previously suggested. However, it seems to be a crafty little bug attacking just about any organ system it lands on.

I don’t think any of us are surprised that the elderly population with weakened immune systems, particularly those in congregate housing, has been much more vulnerable. However, many of the deaths among younger apparently healthy people have defied explanation. The anecdotal observations that physicians, particularly those who practice in-your-face medicine (e.g., ophthalmologists and otolaryngologists) may be more vulnerable raises the issue of viral load. It may be that, although it can be extremely contagious, the virus is not terribly dangerous for most people until the inoculum dose of the virus reaches a certain level. To my knowledge this dose is unknown.

A published survey of more than 300 outbreaks from 120 Chinese cities also may support my suspicion that viral load is of critical importance. The researchers found that all the “identified outbreaks of three or more cases occurred in an indoor environment, which confirms that sharing indoor space is a major SARS-CoV-2 infection risk” (Huan Qian et al. “Indoor transmission of SARS-CoV-2,” MedRxiv. 2020 Apr 7. doi: 10.1101/2020.04.04.20053058). Again, this data shouldn’t surprise us when we look back at what little we know about the outbreaks in the confined spaces on cruise ships and in nursing homes.

I’m not sure that we have any data that helps us determine whether wearing a mask in an outdoor space has any more than symbolic value when we are talking about this particular virus. We may read that the virus in a droplet can survive on the surface it lands on for 8 minutes, and we can see those slow motion videos of the impressive plume of snot spray released by a sneeze. It would seem obvious that even outside someone within 10 feet of the sneeze has a good chance of being infected. However, how much of a threat is the asymptomatic carrier who passes within three feet of you while you are out on lovely summer day stroll? This armchair epidemiologist suspects that, when we are talking about an outside space, the 6-foot guideline for small groups of a dozen or less is overly restrictive. But until we know, I’m staying put in my armchair ... outside on the porch overlooking Casco Bay.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no disclosures. Email him at [email protected].

Real epidemiologists are out knocking on doors, chasing down contacts, or hunched over their computers trying to make sense out of screens full of data and maps. A few are trying valiantly to talk some sense into our elected officials.

konradlew/Thinkstock

This leaves the rest of us with time on our hands to fabricate our own less-than-scientific explanations for the behavior of the SARS-CoV-2 virus. So I have decided to put on hold my current mental challenge of choosing which pasta shape to pair with the sauce I’ve prepared from an online recipe. Here is my educated guess based on what I can glean from media sources that may have been filtered through a variety politically biased lenses. Remember, I did go to medical school; however, when I was in college the DNA helix was still just theoretical.

From those halcyon days of mid-February when our attention was focused on the Diamond Princess quarantined in Yokohama Harbor, it didn’t take a board-certified epidemiologist to suspect that the virus was spreading through the ventilating system in the ship’s tight quarters. Subsequent outbreaks on U.S. and French military ships suggests a similar explanation.

While still not proven, it sounds like SARS-CoV-2 jumped to humans from bats. It should not surprise us that having evolved in a dense population of mammals it would thrive in other high-density populations such as New York and nursing homes. Because we have lacked a robust testing capability, it has been less obvious until recently that, while it is easily transmitted, the virus has infected many who are asymptomatic (“Antibody surveys suggesting vast undercount of coronavirus infections may be unreliable,” Gretchen Vogel, Science, April 21, 2020). Subsequent surveys seem to confirm this higher level carrier state; it suggests that the virus is far less deadly than was previously suggested. However, it seems to be a crafty little bug attacking just about any organ system it lands on.

I don’t think any of us are surprised that the elderly population with weakened immune systems, particularly those in congregate housing, has been much more vulnerable. However, many of the deaths among younger apparently healthy people have defied explanation. The anecdotal observations that physicians, particularly those who practice in-your-face medicine (e.g., ophthalmologists and otolaryngologists) may be more vulnerable raises the issue of viral load. It may be that, although it can be extremely contagious, the virus is not terribly dangerous for most people until the inoculum dose of the virus reaches a certain level. To my knowledge this dose is unknown.

A published survey of more than 300 outbreaks from 120 Chinese cities also may support my suspicion that viral load is of critical importance. The researchers found that all the “identified outbreaks of three or more cases occurred in an indoor environment, which confirms that sharing indoor space is a major SARS-CoV-2 infection risk” (Huan Qian et al. “Indoor transmission of SARS-CoV-2,” MedRxiv. 2020 Apr 7. doi: 10.1101/2020.04.04.20053058). Again, this data shouldn’t surprise us when we look back at what little we know about the outbreaks in the confined spaces on cruise ships and in nursing homes.

I’m not sure that we have any data that helps us determine whether wearing a mask in an outdoor space has any more than symbolic value when we are talking about this particular virus. We may read that the virus in a droplet can survive on the surface it lands on for 8 minutes, and we can see those slow motion videos of the impressive plume of snot spray released by a sneeze. It would seem obvious that even outside someone within 10 feet of the sneeze has a good chance of being infected. However, how much of a threat is the asymptomatic carrier who passes within three feet of you while you are out on lovely summer day stroll? This armchair epidemiologist suspects that, when we are talking about an outside space, the 6-foot guideline for small groups of a dozen or less is overly restrictive. But until we know, I’m staying put in my armchair ... outside on the porch overlooking Casco Bay.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no disclosures. Email him at [email protected].

Real epidemiologists are out knocking on doors, chasing down contacts, or hunched over their computers trying to make sense out of screens full of data and maps. A few are trying valiantly to talk some sense into our elected officials.

konradlew/Thinkstock

This leaves the rest of us with time on our hands to fabricate our own less-than-scientific explanations for the behavior of the SARS-CoV-2 virus. So I have decided to put on hold my current mental challenge of choosing which pasta shape to pair with the sauce I’ve prepared from an online recipe. Here is my educated guess based on what I can glean from media sources that may have been filtered through a variety politically biased lenses. Remember, I did go to medical school; however, when I was in college the DNA helix was still just theoretical.

From those halcyon days of mid-February when our attention was focused on the Diamond Princess quarantined in Yokohama Harbor, it didn’t take a board-certified epidemiologist to suspect that the virus was spreading through the ventilating system in the ship’s tight quarters. Subsequent outbreaks on U.S. and French military ships suggests a similar explanation.

While still not proven, it sounds like SARS-CoV-2 jumped to humans from bats. It should not surprise us that having evolved in a dense population of mammals it would thrive in other high-density populations such as New York and nursing homes. Because we have lacked a robust testing capability, it has been less obvious until recently that, while it is easily transmitted, the virus has infected many who are asymptomatic (“Antibody surveys suggesting vast undercount of coronavirus infections may be unreliable,” Gretchen Vogel, Science, April 21, 2020). Subsequent surveys seem to confirm this higher level carrier state; it suggests that the virus is far less deadly than was previously suggested. However, it seems to be a crafty little bug attacking just about any organ system it lands on.

I don’t think any of us are surprised that the elderly population with weakened immune systems, particularly those in congregate housing, has been much more vulnerable. However, many of the deaths among younger apparently healthy people have defied explanation. The anecdotal observations that physicians, particularly those who practice in-your-face medicine (e.g., ophthalmologists and otolaryngologists) may be more vulnerable raises the issue of viral load. It may be that, although it can be extremely contagious, the virus is not terribly dangerous for most people until the inoculum dose of the virus reaches a certain level. To my knowledge this dose is unknown.

A published survey of more than 300 outbreaks from 120 Chinese cities also may support my suspicion that viral load is of critical importance. The researchers found that all the “identified outbreaks of three or more cases occurred in an indoor environment, which confirms that sharing indoor space is a major SARS-CoV-2 infection risk” (Huan Qian et al. “Indoor transmission of SARS-CoV-2,” MedRxiv. 2020 Apr 7. doi: 10.1101/2020.04.04.20053058). Again, this data shouldn’t surprise us when we look back at what little we know about the outbreaks in the confined spaces on cruise ships and in nursing homes.

I’m not sure that we have any data that helps us determine whether wearing a mask in an outdoor space has any more than symbolic value when we are talking about this particular virus. We may read that the virus in a droplet can survive on the surface it lands on for 8 minutes, and we can see those slow motion videos of the impressive plume of snot spray released by a sneeze. It would seem obvious that even outside someone within 10 feet of the sneeze has a good chance of being infected. However, how much of a threat is the asymptomatic carrier who passes within three feet of you while you are out on lovely summer day stroll? This armchair epidemiologist suspects that, when we are talking about an outside space, the 6-foot guideline for small groups of a dozen or less is overly restrictive. But until we know, I’m staying put in my armchair ... outside on the porch overlooking Casco Bay.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” He has no disclosures. Email him at [email protected].

Keeping hematologic oncology patients on their treatment regimens and caring for inpatients with hematologic malignancies remained “manageable” during the first 2 months of the COVID-19 pandemic at Levine Cancer Institute in Charlotte, N.C.

That level of manageability has partly been because a surge in cases so far hasn’t arrived at Levine or in most of the surrounding North Carolina and South Carolina communities it serves. As of May 15, 2020, the total number of confirmed and reported COVID-19 cases had reached about 19,000 in North Carolina, and just under 9,000 in South Carolina, out of a total population in the two states of close to 16 million. What’s happened instead at Levine Cancer Institute (LCI) has been a steady but low drumbeat of cases that, by mid-May 2020, totaled fewer than 10 patients with hematologic malignancies diagnosed with COVID-19.

“For a large system with multiple sites throughout North and South Carolina that saw 17,200 new patients in 2019 – including solid tumor, benign hematology, and malignant hematology patients – with 198,000 total patient visits, it is safe to say that we are off to a good start. However, we remain in the early throes of the pandemic and we will need to remain vigilant going forward,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in LCI’s Department of Hematologic Oncology and Blood Disorders.

The limited effects to date of COVID-19 at LCI has been thanks to a regimen of great caution for preventing infections that’s been consistently conveyed to LCI patients from before the pandemic’s onset, liberal testing that started early, a proactive plan to defer and temporarily replace infusion care when medically appropriate, a novel staffing approach designed to minimize and contain potential staff outbreaks, and an early pivot to virtual patient contact when feasible.

COVID-19 has had limited penetration into the LCI case load because patients have, in general, “been very careful,” said Dr. Voorhees.

“My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious even before the coronavirus using distancing, masking, and meticulous hand hygiene,” he said in an interview that reviewed the steps LCI took starting in March to confront and manage the effects of the then-nascent pandemic. “Since we started screening asymptomatic patients in the inpatient and outpatient settings we have identified only one patient with COVID-19 infection, which supports the low rate of infection in our patient population thus far.”

Another key step was the launch of “robust” testing for the COVID-19 virus starting on March 9, using an in-house assay from LCI’s parent health system, Atrium Health, that delivered results within 24 hours. Testing became available at LCI “earlier than at many other health systems.” At first, testing was limited to patients or staff presenting with symptoms, but in the following weeks, it expanded to more patients, including those without symptoms who were scheduled for treatment at the apheresis center, cell donors and cell recipients, patients arriving for inpatient chemotherapy or cellular therapy, patients arriving from a skilled nursing facility or similar environments, and more recently, outpatient chemotherapy patients. “We’re now doing a lot of screening,” Dr. Voorhees said. “In general, screening has been well received because patients recognize that it’s for their own safety.”

Another piece of COVID-19 preparedness was a move toward technology as an alternative to face-to-face encounters between patients and staff. “We adopted virtual technology early.” When medically appropriate, they provided either video consultations with more tech-savvy patients or telephone-based virtual visits for patients who preferred a more familiar interface. As LCI starts the process of reentry for patients whose face-to-face encounters were deferred, virtual visits will remain an important facet of maintaining care while limiting exposure for appropriate patients and facilitating adequate space for social distancing in the clinics and infusion centers.

Atrium Health also launched a “virtual hospital” geared to intensified remote management of COVID-19 patients who aren’t sick enough for hospitalization. “People who test positive automatically enter the virtual hospital and have regular interactions with their team of providers,” with LCI providing additional support for their patients who get infected. Patients receive an equipment kit that lets them monitor and transmit their vital signs. The virtual hospital program also helps expedite personal needs like delivery of prescriptions and food. “It helps patients manage at home, and has been incredibly useful,” said Dr. Voorhees.

Perhaps the most challenging step LCI clinicians took to preclude a potential COVID-19 case surge was to review all patients receiving infusional therapy or planned cellular therapy and triage those who could potentially tolerate a temporary change to either an oral, at-home regimen or to a brief hold on their treatment. Some patients on maintenance, outpatient infusion-therapy regimens “expressed concern about coming to the clinic. We looked at the patients scheduled to come for infusions and decided which visits were essential and which were deferrable without disrupting care by briefly using a noninfusional approach,” said Dr. Voorhees. The number of patients who had their regimens modified or held was “relatively small,” and with the recent recognition that a surge of infections has not occurred, “we’re now rolling out cautious reentry of those patients back to their originally prescribed chemotherapy.”

In addition to concerns of exposure at infusion clinics, there are concerns about the heightened susceptibility of immunosuppressed hematologic oncology patients to COVID-19 and their risk for more severe infection. “Our view is that, if patients tested positive, continuing immunosuppressive treatment would likely be detrimental,” so when possible treatment is temporarily suspended and then resumed when the infection has cleared. “When patients test positive for a prolonged period, a decision to resume treatment must be in the best interests of the patient and weigh the benefits of resuming therapy against the risks of incurring a more severe infection by restarting potentially immunosuppressive therapy,” Dr. Voorhees said.

The enhanced risk that cancer patients face if they develop COVID-19 was documented in a recent review of 218 cancer patients hospitalized for COVID-19 during parts of March and April in a large New York health system. The results showed an overall mortality rate of 28%, including a 37% rate among 54 patients with hematologic malignancies and a 25% rate among 164 patients with solid tumors. The mortality rate “may not be quite as high as they reported because that depends on how many patients you test, but there is no question that patients with more comorbidities are at higher risk. Patients with active cancer on chemotherapy are a particularly vulnerable population, and many have expressed concerns about their vulnerability,” he observed.

For the few LCI patients who developed COVID-19 infection, the medical staff has had several therapeutic options they could match to each patient’s needs, with help from the Atrium Health infectious disease team. LCI and Atrium Health are participating in several COVID-19 clinical treatment trials, including an investigational convalescent plasma protocol spearheaded by the Mayo Clinic. They have also opened a randomized, phase 2 trial evaluating the safety and efficacy of selinexor (Xpovio), an oral drug that’s Food and Drug Administration approved for patients with multiple myeloma, for treatment of moderate or severe COVID-19 infection. Additional studies evaluating blockade of granulocyte-macrophage colony-stimulating factor, as well as inhaled antiviral therapy, have recently launched, and several additional studies are poised to open in the coming weeks.

The LCI and Atrium Health team also has a supply of the antiviral agent remdesivir as part of the FDA’s expanded access protocol and emergency use authorization. They also have a supply of and experience administering the interleukin-6 receptor inhibitor tocilizumab (Actemra), which showed some suggestion of efficacy in limited experience treating patients with severe or critical COVID-19 infections (Proc Natl Acad Sci. 2020 Apr 29; doi: 10.1073/pnas.2005615117). Clinicians at LCI have not used the investigational and unproven agents hydroxychloroquine, chloroquine, and azithromycin to either prevent or treat COVID-19.

LCI also instituted measures to try to minimize the risk that staff members could become infected and transmit the virus while asymptomatic. Following conversations held early on with COVID-19–experienced health authorities in China and Italy, the patient-facing LCI staff split into two teams starting on March 23 that alternated responsibility for direct patient interactions every 2 weeks. When one of these teams was off from direct patient contact they continued to care for patients remotely through virtual technologies. The concept was that, if a staffer became infected while remaining asymptomatic during their contact with patients, their status would either become diagnosable or resolve during their 2 weeks away from seeing any patients. Perhaps in part because of this approach infections among staff members “have not been a big issue. We’ve had an incredibly low infection rate among the LCI staff,” Dr. Voorhees noted.

By mid-May, with the imminent threat of a sudden CODIV-19 surge moderated, heme-onc operations at LCI began to cautiously revert to more normal operations. “We’re continuing patient screening for signs and symptoms of COVID-19 infection, testing for asymptomatic infections, and requiring masking and social distancing in the clinics and hospitals, but we’re starting to slowly restore the number of patients at our clinics [virtual and face to face[ and infusion centers,” and the staff’s division into two teams ended. “The idea was to get past a surge and make sure our system was not overwhelmed. We anticipated a local surge in late April, but then it kept getting pushed back. Current projections are for the infection rate among LCI patients to remain low provided that community spread remains stable or, ideally, decreases.” The LCI infectious disease staff is closely monitoring infection rates for early recognition of an outbreak, with plans to follow any new cases with contact tracing. So far, the COVID-19 pandemic at LCI “has been very manageable,” Dr. Voorhees concluded.

“We’re now better positioned to deal with a case surge if it were to happen. We could resume the two-team approach, hospital-wide plans are now in place for a future surge, and we are now up and running with robust testing and inpatient and outpatient virtual technology. The first time, we were all learning on the fly.”

The LCI biostatistics team has been prospectively collecting the Institutes’s COVID-19 patient data, with plans to report their findings.

Dr. Voorhees has had financial relationships with Bristol-Myers Squibb/Celgene, Janssen, Novartis, and Oncopeptides, none of which are relevant to this article.

[email protected]

Keeping hematologic oncology patients on their treatment regimens and caring for inpatients with hematologic malignancies remained “manageable” during the first 2 months of the COVID-19 pandemic at Levine Cancer Institute in Charlotte, N.C.

That level of manageability has partly been because a surge in cases so far hasn’t arrived at Levine or in most of the surrounding North Carolina and South Carolina communities it serves. As of May 15, 2020, the total number of confirmed and reported COVID-19 cases had reached about 19,000 in North Carolina, and just under 9,000 in South Carolina, out of a total population in the two states of close to 16 million. What’s happened instead at Levine Cancer Institute (LCI) has been a steady but low drumbeat of cases that, by mid-May 2020, totaled fewer than 10 patients with hematologic malignancies diagnosed with COVID-19.

“For a large system with multiple sites throughout North and South Carolina that saw 17,200 new patients in 2019 – including solid tumor, benign hematology, and malignant hematology patients – with 198,000 total patient visits, it is safe to say that we are off to a good start. However, we remain in the early throes of the pandemic and we will need to remain vigilant going forward,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in LCI’s Department of Hematologic Oncology and Blood Disorders.

The limited effects to date of COVID-19 at LCI has been thanks to a regimen of great caution for preventing infections that’s been consistently conveyed to LCI patients from before the pandemic’s onset, liberal testing that started early, a proactive plan to defer and temporarily replace infusion care when medically appropriate, a novel staffing approach designed to minimize and contain potential staff outbreaks, and an early pivot to virtual patient contact when feasible.

COVID-19 has had limited penetration into the LCI case load because patients have, in general, “been very careful,” said Dr. Voorhees.

“My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious even before the coronavirus using distancing, masking, and meticulous hand hygiene,” he said in an interview that reviewed the steps LCI took starting in March to confront and manage the effects of the then-nascent pandemic. “Since we started screening asymptomatic patients in the inpatient and outpatient settings we have identified only one patient with COVID-19 infection, which supports the low rate of infection in our patient population thus far.”

Another key step was the launch of “robust” testing for the COVID-19 virus starting on March 9, using an in-house assay from LCI’s parent health system, Atrium Health, that delivered results within 24 hours. Testing became available at LCI “earlier than at many other health systems.” At first, testing was limited to patients or staff presenting with symptoms, but in the following weeks, it expanded to more patients, including those without symptoms who were scheduled for treatment at the apheresis center, cell donors and cell recipients, patients arriving for inpatient chemotherapy or cellular therapy, patients arriving from a skilled nursing facility or similar environments, and more recently, outpatient chemotherapy patients. “We’re now doing a lot of screening,” Dr. Voorhees said. “In general, screening has been well received because patients recognize that it’s for their own safety.”

Another piece of COVID-19 preparedness was a move toward technology as an alternative to face-to-face encounters between patients and staff. “We adopted virtual technology early.” When medically appropriate, they provided either video consultations with more tech-savvy patients or telephone-based virtual visits for patients who preferred a more familiar interface. As LCI starts the process of reentry for patients whose face-to-face encounters were deferred, virtual visits will remain an important facet of maintaining care while limiting exposure for appropriate patients and facilitating adequate space for social distancing in the clinics and infusion centers.

Atrium Health also launched a “virtual hospital” geared to intensified remote management of COVID-19 patients who aren’t sick enough for hospitalization. “People who test positive automatically enter the virtual hospital and have regular interactions with their team of providers,” with LCI providing additional support for their patients who get infected. Patients receive an equipment kit that lets them monitor and transmit their vital signs. The virtual hospital program also helps expedite personal needs like delivery of prescriptions and food. “It helps patients manage at home, and has been incredibly useful,” said Dr. Voorhees.

Perhaps the most challenging step LCI clinicians took to preclude a potential COVID-19 case surge was to review all patients receiving infusional therapy or planned cellular therapy and triage those who could potentially tolerate a temporary change to either an oral, at-home regimen or to a brief hold on their treatment. Some patients on maintenance, outpatient infusion-therapy regimens “expressed concern about coming to the clinic. We looked at the patients scheduled to come for infusions and decided which visits were essential and which were deferrable without disrupting care by briefly using a noninfusional approach,” said Dr. Voorhees. The number of patients who had their regimens modified or held was “relatively small,” and with the recent recognition that a surge of infections has not occurred, “we’re now rolling out cautious reentry of those patients back to their originally prescribed chemotherapy.”

In addition to concerns of exposure at infusion clinics, there are concerns about the heightened susceptibility of immunosuppressed hematologic oncology patients to COVID-19 and their risk for more severe infection. “Our view is that, if patients tested positive, continuing immunosuppressive treatment would likely be detrimental,” so when possible treatment is temporarily suspended and then resumed when the infection has cleared. “When patients test positive for a prolonged period, a decision to resume treatment must be in the best interests of the patient and weigh the benefits of resuming therapy against the risks of incurring a more severe infection by restarting potentially immunosuppressive therapy,” Dr. Voorhees said.

The enhanced risk that cancer patients face if they develop COVID-19 was documented in a recent review of 218 cancer patients hospitalized for COVID-19 during parts of March and April in a large New York health system. The results showed an overall mortality rate of 28%, including a 37% rate among 54 patients with hematologic malignancies and a 25% rate among 164 patients with solid tumors. The mortality rate “may not be quite as high as they reported because that depends on how many patients you test, but there is no question that patients with more comorbidities are at higher risk. Patients with active cancer on chemotherapy are a particularly vulnerable population, and many have expressed concerns about their vulnerability,” he observed.

For the few LCI patients who developed COVID-19 infection, the medical staff has had several therapeutic options they could match to each patient’s needs, with help from the Atrium Health infectious disease team. LCI and Atrium Health are participating in several COVID-19 clinical treatment trials, including an investigational convalescent plasma protocol spearheaded by the Mayo Clinic. They have also opened a randomized, phase 2 trial evaluating the safety and efficacy of selinexor (Xpovio), an oral drug that’s Food and Drug Administration approved for patients with multiple myeloma, for treatment of moderate or severe COVID-19 infection. Additional studies evaluating blockade of granulocyte-macrophage colony-stimulating factor, as well as inhaled antiviral therapy, have recently launched, and several additional studies are poised to open in the coming weeks.

The LCI and Atrium Health team also has a supply of the antiviral agent remdesivir as part of the FDA’s expanded access protocol and emergency use authorization. They also have a supply of and experience administering the interleukin-6 receptor inhibitor tocilizumab (Actemra), which showed some suggestion of efficacy in limited experience treating patients with severe or critical COVID-19 infections (Proc Natl Acad Sci. 2020 Apr 29; doi: 10.1073/pnas.2005615117). Clinicians at LCI have not used the investigational and unproven agents hydroxychloroquine, chloroquine, and azithromycin to either prevent or treat COVID-19.

LCI also instituted measures to try to minimize the risk that staff members could become infected and transmit the virus while asymptomatic. Following conversations held early on with COVID-19–experienced health authorities in China and Italy, the patient-facing LCI staff split into two teams starting on March 23 that alternated responsibility for direct patient interactions every 2 weeks. When one of these teams was off from direct patient contact they continued to care for patients remotely through virtual technologies. The concept was that, if a staffer became infected while remaining asymptomatic during their contact with patients, their status would either become diagnosable or resolve during their 2 weeks away from seeing any patients. Perhaps in part because of this approach infections among staff members “have not been a big issue. We’ve had an incredibly low infection rate among the LCI staff,” Dr. Voorhees noted.

By mid-May, with the imminent threat of a sudden CODIV-19 surge moderated, heme-onc operations at LCI began to cautiously revert to more normal operations. “We’re continuing patient screening for signs and symptoms of COVID-19 infection, testing for asymptomatic infections, and requiring masking and social distancing in the clinics and hospitals, but we’re starting to slowly restore the number of patients at our clinics [virtual and face to face[ and infusion centers,” and the staff’s division into two teams ended. “The idea was to get past a surge and make sure our system was not overwhelmed. We anticipated a local surge in late April, but then it kept getting pushed back. Current projections are for the infection rate among LCI patients to remain low provided that community spread remains stable or, ideally, decreases.” The LCI infectious disease staff is closely monitoring infection rates for early recognition of an outbreak, with plans to follow any new cases with contact tracing. So far, the COVID-19 pandemic at LCI “has been very manageable,” Dr. Voorhees concluded.

“We’re now better positioned to deal with a case surge if it were to happen. We could resume the two-team approach, hospital-wide plans are now in place for a future surge, and we are now up and running with robust testing and inpatient and outpatient virtual technology. The first time, we were all learning on the fly.”

The LCI biostatistics team has been prospectively collecting the Institutes’s COVID-19 patient data, with plans to report their findings.

Dr. Voorhees has had financial relationships with Bristol-Myers Squibb/Celgene, Janssen, Novartis, and Oncopeptides, none of which are relevant to this article.

[email protected]

Keeping hematologic oncology patients on their treatment regimens and caring for inpatients with hematologic malignancies remained “manageable” during the first 2 months of the COVID-19 pandemic at Levine Cancer Institute in Charlotte, N.C.

That level of manageability has partly been because a surge in cases so far hasn’t arrived at Levine or in most of the surrounding North Carolina and South Carolina communities it serves. As of May 15, 2020, the total number of confirmed and reported COVID-19 cases had reached about 19,000 in North Carolina, and just under 9,000 in South Carolina, out of a total population in the two states of close to 16 million. What’s happened instead at Levine Cancer Institute (LCI) has been a steady but low drumbeat of cases that, by mid-May 2020, totaled fewer than 10 patients with hematologic malignancies diagnosed with COVID-19.

“For a large system with multiple sites throughout North and South Carolina that saw 17,200 new patients in 2019 – including solid tumor, benign hematology, and malignant hematology patients – with 198,000 total patient visits, it is safe to say that we are off to a good start. However, we remain in the early throes of the pandemic and we will need to remain vigilant going forward,” said Peter Voorhees, MD, professor of medicine and director of Medical Operations and Outreach Services in LCI’s Department of Hematologic Oncology and Blood Disorders.

The limited effects to date of COVID-19 at LCI has been thanks to a regimen of great caution for preventing infections that’s been consistently conveyed to LCI patients from before the pandemic’s onset, liberal testing that started early, a proactive plan to defer and temporarily replace infusion care when medically appropriate, a novel staffing approach designed to minimize and contain potential staff outbreaks, and an early pivot to virtual patient contact when feasible.

COVID-19 has had limited penetration into the LCI case load because patients have, in general, “been very careful,” said Dr. Voorhees.

“My impression is that the incidence has been low partly because our patients, especially those with hematologic malignancies including those on active chemotherapy, were already getting warned to be cautious even before the coronavirus using distancing, masking, and meticulous hand hygiene,” he said in an interview that reviewed the steps LCI took starting in March to confront and manage the effects of the then-nascent pandemic. “Since we started screening asymptomatic patients in the inpatient and outpatient settings we have identified only one patient with COVID-19 infection, which supports the low rate of infection in our patient population thus far.”

Another key step was the launch of “robust” testing for the COVID-19 virus starting on March 9, using an in-house assay from LCI’s parent health system, Atrium Health, that delivered results within 24 hours. Testing became available at LCI “earlier than at many other health systems.” At first, testing was limited to patients or staff presenting with symptoms, but in the following weeks, it expanded to more patients, including those without symptoms who were scheduled for treatment at the apheresis center, cell donors and cell recipients, patients arriving for inpatient chemotherapy or cellular therapy, patients arriving from a skilled nursing facility or similar environments, and more recently, outpatient chemotherapy patients. “We’re now doing a lot of screening,” Dr. Voorhees said. “In general, screening has been well received because patients recognize that it’s for their own safety.”

Another piece of COVID-19 preparedness was a move toward technology as an alternative to face-to-face encounters between patients and staff. “We adopted virtual technology early.” When medically appropriate, they provided either video consultations with more tech-savvy patients or telephone-based virtual visits for patients who preferred a more familiar interface. As LCI starts the process of reentry for patients whose face-to-face encounters were deferred, virtual visits will remain an important facet of maintaining care while limiting exposure for appropriate patients and facilitating adequate space for social distancing in the clinics and infusion centers.

Atrium Health also launched a “virtual hospital” geared to intensified remote management of COVID-19 patients who aren’t sick enough for hospitalization. “People who test positive automatically enter the virtual hospital and have regular interactions with their team of providers,” with LCI providing additional support for their patients who get infected. Patients receive an equipment kit that lets them monitor and transmit their vital signs. The virtual hospital program also helps expedite personal needs like delivery of prescriptions and food. “It helps patients manage at home, and has been incredibly useful,” said Dr. Voorhees.

Perhaps the most challenging step LCI clinicians took to preclude a potential COVID-19 case surge was to review all patients receiving infusional therapy or planned cellular therapy and triage those who could potentially tolerate a temporary change to either an oral, at-home regimen or to a brief hold on their treatment. Some patients on maintenance, outpatient infusion-therapy regimens “expressed concern about coming to the clinic. We looked at the patients scheduled to come for infusions and decided which visits were essential and which were deferrable without disrupting care by briefly using a noninfusional approach,” said Dr. Voorhees. The number of patients who had their regimens modified or held was “relatively small,” and with the recent recognition that a surge of infections has not occurred, “we’re now rolling out cautious reentry of those patients back to their originally prescribed chemotherapy.”

In addition to concerns of exposure at infusion clinics, there are concerns about the heightened susceptibility of immunosuppressed hematologic oncology patients to COVID-19 and their risk for more severe infection. “Our view is that, if patients tested positive, continuing immunosuppressive treatment would likely be detrimental,” so when possible treatment is temporarily suspended and then resumed when the infection has cleared. “When patients test positive for a prolonged period, a decision to resume treatment must be in the best interests of the patient and weigh the benefits of resuming therapy against the risks of incurring a more severe infection by restarting potentially immunosuppressive therapy,” Dr. Voorhees said.

The enhanced risk that cancer patients face if they develop COVID-19 was documented in a recent review of 218 cancer patients hospitalized for COVID-19 during parts of March and April in a large New York health system. The results showed an overall mortality rate of 28%, including a 37% rate among 54 patients with hematologic malignancies and a 25% rate among 164 patients with solid tumors. The mortality rate “may not be quite as high as they reported because that depends on how many patients you test, but there is no question that patients with more comorbidities are at higher risk. Patients with active cancer on chemotherapy are a particularly vulnerable population, and many have expressed concerns about their vulnerability,” he observed.

For the few LCI patients who developed COVID-19 infection, the medical staff has had several therapeutic options they could match to each patient’s needs, with help from the Atrium Health infectious disease team. LCI and Atrium Health are participating in several COVID-19 clinical treatment trials, including an investigational convalescent plasma protocol spearheaded by the Mayo Clinic. They have also opened a randomized, phase 2 trial evaluating the safety and efficacy of selinexor (Xpovio), an oral drug that’s Food and Drug Administration approved for patients with multiple myeloma, for treatment of moderate or severe COVID-19 infection. Additional studies evaluating blockade of granulocyte-macrophage colony-stimulating factor, as well as inhaled antiviral therapy, have recently launched, and several additional studies are poised to open in the coming weeks.

The LCI and Atrium Health team also has a supply of the antiviral agent remdesivir as part of the FDA’s expanded access protocol and emergency use authorization. They also have a supply of and experience administering the interleukin-6 receptor inhibitor tocilizumab (Actemra), which showed some suggestion of efficacy in limited experience treating patients with severe or critical COVID-19 infections (Proc Natl Acad Sci. 2020 Apr 29; doi: 10.1073/pnas.2005615117). Clinicians at LCI have not used the investigational and unproven agents hydroxychloroquine, chloroquine, and azithromycin to either prevent or treat COVID-19.

LCI also instituted measures to try to minimize the risk that staff members could become infected and transmit the virus while asymptomatic. Following conversations held early on with COVID-19–experienced health authorities in China and Italy, the patient-facing LCI staff split into two teams starting on March 23 that alternated responsibility for direct patient interactions every 2 weeks. When one of these teams was off from direct patient contact they continued to care for patients remotely through virtual technologies. The concept was that, if a staffer became infected while remaining asymptomatic during their contact with patients, their status would either become diagnosable or resolve during their 2 weeks away from seeing any patients. Perhaps in part because of this approach infections among staff members “have not been a big issue. We’ve had an incredibly low infection rate among the LCI staff,” Dr. Voorhees noted.

By mid-May, with the imminent threat of a sudden CODIV-19 surge moderated, heme-onc operations at LCI began to cautiously revert to more normal operations. “We’re continuing patient screening for signs and symptoms of COVID-19 infection, testing for asymptomatic infections, and requiring masking and social distancing in the clinics and hospitals, but we’re starting to slowly restore the number of patients at our clinics [virtual and face to face[ and infusion centers,” and the staff’s division into two teams ended. “The idea was to get past a surge and make sure our system was not overwhelmed. We anticipated a local surge in late April, but then it kept getting pushed back. Current projections are for the infection rate among LCI patients to remain low provided that community spread remains stable or, ideally, decreases.” The LCI infectious disease staff is closely monitoring infection rates for early recognition of an outbreak, with plans to follow any new cases with contact tracing. So far, the COVID-19 pandemic at LCI “has been very manageable,” Dr. Voorhees concluded.

“We’re now better positioned to deal with a case surge if it were to happen. We could resume the two-team approach, hospital-wide plans are now in place for a future surge, and we are now up and running with robust testing and inpatient and outpatient virtual technology. The first time, we were all learning on the fly.”

The LCI biostatistics team has been prospectively collecting the Institutes’s COVID-19 patient data, with plans to report their findings.

Dr. Voorhees has had financial relationships with Bristol-Myers Squibb/Celgene, Janssen, Novartis, and Oncopeptides, none of which are relevant to this article.

[email protected]