MDedge Psychiatry

COVID-19 has prompted many changes in pediatric health care. They say necessity is the mother of invention. Sometimes, necessity is the motivator for the long-past-due adoption of a previous invention, such as telemedicine for minor illnesses. And sometimes necessity reminds us about what is really important in a world of high technology.

Nicola Marfisi/AGF/Universal Images Group/Science Source

Unlike our nearly overwhelmed internal medicine, ED, and family physician colleagues, many pediatricians are in a lull that threatens the financial viability of our practices. We are postponing annual well visits. We have fewer sick visits and hospitalizations since respiratory syncytial virus (RSV) and influenza also have been reduced by social distancing. Parents are avoiding the risk of contagion in the waiting room and not bringing their children in for minor complaints. There is more telemedicine – a welcome change in financing and practice whose time has come, but was being delayed by lack of insurance coverage.

Technology has allowed clinicians to respond to the pandemic in ways that would not have been possible a few years ago. Online tools, such as subscription email lists, webinars, and electronic medical news services, provide updates when the information changes weekly on the virus’s contagiousness, asymptomatic and presymptomatic transmission, prevalence, the effectiveness of masks, and experimental treatment options. These changes have been so fast that many journal articles based on data from China were obsolete and contradicted before they appeared in print.

However, technology only helped us to more effectively do what we needed to do in the first place – come together in a world of physical distancing and work toward common goals. In many hospitals, pediatric wards were emptied by reduced RSV admissions and postponed elective surgeries. These units have been converted to accept adult patients up to age 30 or 40 years. Our med-peds colleagues quickly created webinars and online resource packages on topics pediatric hospitalists might need to care for that population. There were refresher courses on ventilator management and reminders that community pediatric hospitalists, who in the winter might have one-third of their admissions with RSV, have more experience managing viral pneumonia than the internists.

Ward teams were created with a pediatric attending and an internal medicine resident. The resident’s familiarity with the names of blood pressure medicines complemented the attending’s years of clinical judgment and bedside manner. People are stepping out of their comfort zones but initial reports from the front lines are that, with each other’s support, we’ve got this.

Mistakes in telemedicine are being made, shared, and learned from. Emergency physicians are collecting anecdotes of situations when things were missed or treatment delayed. Surgeons report seeing increased numbers of cases in which the diagnosis of appendicitis was delayed, which isn’t surprising when a pediatrician cannot lay hands on the belly. Perhaps any case in which a parent calls a second or third time should be seen in the flesh.

Some newborn nurseries are discharging mother and baby at 24 hours after birth and rediscovering what was learned about that practice, which became common in the 1990s. It works well for the vast majority of babies, but we need to be ready to detect the occasional jaundiced baby or the one where breastfeeding isn’t going well. The gray-haired pediatricians can recall those nuances.

Another key role is to help everyone process the frequent deaths during a pandemic. First, there are the families we care for. Children are losing grandparents with little warning. Parents may be overwhelmed with grief while ill themselves. That makes children vulnerable.

Our medical system in 2 months has moved heaven and earth – and significantly harmed the medical care and financial future of our children – trying to assure that every 80-year-old has the right to die while attached to a ventilator, even though only a small fraction of them will survive to discharge. Meanwhile, on the wards, visitation policies have people deteriorating and dying alone. I find this paradigm distressing and antithetical to my training.

Medicine and nursing both have long histories in which the practitioner recognized that there was little they could do to prevent the death. Their role was to compassionately guide the family through it. For some people, this connection is the most precious of the arts of medicine and nursing. We need to reexamine our values. We need to get creative. We need to involve palliative care experts and clergy with the same urgency with which we have automakers making ventilators.

Second, there are our colleagues. Pediatric caregivers, particularly trainees, rarely encounter deaths and can benefit from debriefing sessions, even short ones. There is comfort in having a colleague review the situation and say: “There was nothing you could have done.” Or even: “That minor omission did not alter the outcome.” Even when everything was done properly, deaths cause moral suffering that needs processing and healing. Even if you don’t have magic words to give, just being present aids in the healing. We are all in this, together.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

COVID-19 has prompted many changes in pediatric health care. They say necessity is the mother of invention. Sometimes, necessity is the motivator for the long-past-due adoption of a previous invention, such as telemedicine for minor illnesses. And sometimes necessity reminds us about what is really important in a world of high technology.

Nicola Marfisi/AGF/Universal Images Group/Science Source

Unlike our nearly overwhelmed internal medicine, ED, and family physician colleagues, many pediatricians are in a lull that threatens the financial viability of our practices. We are postponing annual well visits. We have fewer sick visits and hospitalizations since respiratory syncytial virus (RSV) and influenza also have been reduced by social distancing. Parents are avoiding the risk of contagion in the waiting room and not bringing their children in for minor complaints. There is more telemedicine – a welcome change in financing and practice whose time has come, but was being delayed by lack of insurance coverage.

Technology has allowed clinicians to respond to the pandemic in ways that would not have been possible a few years ago. Online tools, such as subscription email lists, webinars, and electronic medical news services, provide updates when the information changes weekly on the virus’s contagiousness, asymptomatic and presymptomatic transmission, prevalence, the effectiveness of masks, and experimental treatment options. These changes have been so fast that many journal articles based on data from China were obsolete and contradicted before they appeared in print.

However, technology only helped us to more effectively do what we needed to do in the first place – come together in a world of physical distancing and work toward common goals. In many hospitals, pediatric wards were emptied by reduced RSV admissions and postponed elective surgeries. These units have been converted to accept adult patients up to age 30 or 40 years. Our med-peds colleagues quickly created webinars and online resource packages on topics pediatric hospitalists might need to care for that population. There were refresher courses on ventilator management and reminders that community pediatric hospitalists, who in the winter might have one-third of their admissions with RSV, have more experience managing viral pneumonia than the internists.

Ward teams were created with a pediatric attending and an internal medicine resident. The resident’s familiarity with the names of blood pressure medicines complemented the attending’s years of clinical judgment and bedside manner. People are stepping out of their comfort zones but initial reports from the front lines are that, with each other’s support, we’ve got this.

Mistakes in telemedicine are being made, shared, and learned from. Emergency physicians are collecting anecdotes of situations when things were missed or treatment delayed. Surgeons report seeing increased numbers of cases in which the diagnosis of appendicitis was delayed, which isn’t surprising when a pediatrician cannot lay hands on the belly. Perhaps any case in which a parent calls a second or third time should be seen in the flesh.

Some newborn nurseries are discharging mother and baby at 24 hours after birth and rediscovering what was learned about that practice, which became common in the 1990s. It works well for the vast majority of babies, but we need to be ready to detect the occasional jaundiced baby or the one where breastfeeding isn’t going well. The gray-haired pediatricians can recall those nuances.

Another key role is to help everyone process the frequent deaths during a pandemic. First, there are the families we care for. Children are losing grandparents with little warning. Parents may be overwhelmed with grief while ill themselves. That makes children vulnerable.

Our medical system in 2 months has moved heaven and earth – and significantly harmed the medical care and financial future of our children – trying to assure that every 80-year-old has the right to die while attached to a ventilator, even though only a small fraction of them will survive to discharge. Meanwhile, on the wards, visitation policies have people deteriorating and dying alone. I find this paradigm distressing and antithetical to my training.

Medicine and nursing both have long histories in which the practitioner recognized that there was little they could do to prevent the death. Their role was to compassionately guide the family through it. For some people, this connection is the most precious of the arts of medicine and nursing. We need to reexamine our values. We need to get creative. We need to involve palliative care experts and clergy with the same urgency with which we have automakers making ventilators.

Second, there are our colleagues. Pediatric caregivers, particularly trainees, rarely encounter deaths and can benefit from debriefing sessions, even short ones. There is comfort in having a colleague review the situation and say: “There was nothing you could have done.” Or even: “That minor omission did not alter the outcome.” Even when everything was done properly, deaths cause moral suffering that needs processing and healing. Even if you don’t have magic words to give, just being present aids in the healing. We are all in this, together.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

COVID-19 has prompted many changes in pediatric health care. They say necessity is the mother of invention. Sometimes, necessity is the motivator for the long-past-due adoption of a previous invention, such as telemedicine for minor illnesses. And sometimes necessity reminds us about what is really important in a world of high technology.

Nicola Marfisi/AGF/Universal Images Group/Science Source

Unlike our nearly overwhelmed internal medicine, ED, and family physician colleagues, many pediatricians are in a lull that threatens the financial viability of our practices. We are postponing annual well visits. We have fewer sick visits and hospitalizations since respiratory syncytial virus (RSV) and influenza also have been reduced by social distancing. Parents are avoiding the risk of contagion in the waiting room and not bringing their children in for minor complaints. There is more telemedicine – a welcome change in financing and practice whose time has come, but was being delayed by lack of insurance coverage.

Technology has allowed clinicians to respond to the pandemic in ways that would not have been possible a few years ago. Online tools, such as subscription email lists, webinars, and electronic medical news services, provide updates when the information changes weekly on the virus’s contagiousness, asymptomatic and presymptomatic transmission, prevalence, the effectiveness of masks, and experimental treatment options. These changes have been so fast that many journal articles based on data from China were obsolete and contradicted before they appeared in print.

However, technology only helped us to more effectively do what we needed to do in the first place – come together in a world of physical distancing and work toward common goals. In many hospitals, pediatric wards were emptied by reduced RSV admissions and postponed elective surgeries. These units have been converted to accept adult patients up to age 30 or 40 years. Our med-peds colleagues quickly created webinars and online resource packages on topics pediatric hospitalists might need to care for that population. There were refresher courses on ventilator management and reminders that community pediatric hospitalists, who in the winter might have one-third of their admissions with RSV, have more experience managing viral pneumonia than the internists.

Ward teams were created with a pediatric attending and an internal medicine resident. The resident’s familiarity with the names of blood pressure medicines complemented the attending’s years of clinical judgment and bedside manner. People are stepping out of their comfort zones but initial reports from the front lines are that, with each other’s support, we’ve got this.

Mistakes in telemedicine are being made, shared, and learned from. Emergency physicians are collecting anecdotes of situations when things were missed or treatment delayed. Surgeons report seeing increased numbers of cases in which the diagnosis of appendicitis was delayed, which isn’t surprising when a pediatrician cannot lay hands on the belly. Perhaps any case in which a parent calls a second or third time should be seen in the flesh.

Some newborn nurseries are discharging mother and baby at 24 hours after birth and rediscovering what was learned about that practice, which became common in the 1990s. It works well for the vast majority of babies, but we need to be ready to detect the occasional jaundiced baby or the one where breastfeeding isn’t going well. The gray-haired pediatricians can recall those nuances.

Another key role is to help everyone process the frequent deaths during a pandemic. First, there are the families we care for. Children are losing grandparents with little warning. Parents may be overwhelmed with grief while ill themselves. That makes children vulnerable.

Our medical system in 2 months has moved heaven and earth – and significantly harmed the medical care and financial future of our children – trying to assure that every 80-year-old has the right to die while attached to a ventilator, even though only a small fraction of them will survive to discharge. Meanwhile, on the wards, visitation policies have people deteriorating and dying alone. I find this paradigm distressing and antithetical to my training.

Medicine and nursing both have long histories in which the practitioner recognized that there was little they could do to prevent the death. Their role was to compassionately guide the family through it. For some people, this connection is the most precious of the arts of medicine and nursing. We need to reexamine our values. We need to get creative. We need to involve palliative care experts and clergy with the same urgency with which we have automakers making ventilators.

Second, there are our colleagues. Pediatric caregivers, particularly trainees, rarely encounter deaths and can benefit from debriefing sessions, even short ones. There is comfort in having a colleague review the situation and say: “There was nothing you could have done.” Or even: “That minor omission did not alter the outcome.” Even when everything was done properly, deaths cause moral suffering that needs processing and healing. Even if you don’t have magic words to give, just being present aids in the healing. We are all in this, together.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at [email protected].

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

As an Episcopal priest, Father Robert Pace of Fort Worth, TX, is used to putting others first and reaching out to help. So when the pulmonologist who helped him through his ordeal with COVID-19 asked if he would like to donate blood to help other patients, he did not hesitate.

“I said, ‘Absolutely,’” Pace, 53, recalls. He says the idea was ‘very appealing.’ ” During his ordeal with COVID-19 in March, he had spent 3 days in the hospital, isolated and on IV fluids and oxygen. He was short of breath, with a heartbeat more rapid than usual.

Now, fully recovered, his blood was a precious commodity, antibody-rich and potentially life-saving.

As researchers scramble to test drugs to fight COVID-19, others are turning to an age-old treatment. They’re collecting the blood of survivors and giving it to patients in the throes of a severe infection, a treatment known as convalescent plasma therapy.

Doctors say the treatment will probably serve as a bridge until other drugs and a vaccine become available.

Although the FDA considers the treatment investigational, in late March, it eased access to it. Patients can get it as part of a clinical trial or through an expanded access program overseen by hospitals or universities. A doctor can also request permission to use the treatment for a single patient.

“It is considered an emergent, compassionate need,” says John Burk, MD, a pulmonologist at Texas Health Harris Methodist Hospital, Fort Worth, who treated Pace. “It is a way to bring it to the bedside.” And the approval can happen quickly. Burk says he got one from the FDA just 20 minutes after requesting it for a severely ill patient.
 

How it works

The premise of how it works is “quite straightforward,” says Michael Joyner, MD, a professor of anesthesiology at the Mayo Clinic, Rochester, MN. “When someone is recovered and no longer symptomatic, you can harvest those antibodies from their blood and give them to someone else, and hopefully alter the course of their disease.” Joyner is the principal investigator for the FDA’s national Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, with 1,000 sites already signed on.

Convalescent therapy has been used to fight many other viruses, including Ebola, severe acute respiratory syndrome (SARS), the “bird” flu, H1N1 flu, and during the 1918 flu pandemic. Joyner says the strongest evidence for it comes from the 1950s, when it was used to treat a rodent-borne illness called Argentine hemorrhagic fever. Using convalescent plasma therapy for this infection reduced the death rate from nearly 43% before the treatment became common in the late 1950s to about 3% after it was widely used, one report found.

Data about convalescent therapy specifically for COVID-19 is limited. Chinese researchers reported on five critically ill patients, all on mechanical ventilation, treated with convalescent plasma after they had received antiviral and anti-inflammatory medicines. Three could leave the hospital after 51-55 days, and two were in stable condition in the hospital 37 days after the transfusion.

In another study of 10 severely ill patients, symptoms went away or improved in all 10 within 1 to 3 days after the transfusion. Two of the three on ventilators were weaned off and put on oxygen instead. None died.

Chinese researchers also reported three cases of patients with COVID-19 given the convalescent therapy who had a satisfactory recovery.

Researchers who reviewed the track record of convalescent therapy for other conditions recently concluded that the treatment doesn’t appear to cause severe side effects and it should be studied for COVID-19.

Although information on side effects specific to this treatment is evolving, Joyner says they are “very, very low.”

According to the FDA, allergic reactions can occur with plasma therapies. Because the treatment for COVID-19 is new, it is not known if patients might have other types of reactions.
 

Who can donate?

Blood bank officials and researchers running the convalescent plasma programs say the desire to help is widespread, and they’ve been deluged with offers to donate. But requirements are strict.

Donors must have evidence of COVID-19 infection, documented in a variety of ways, such as a diagnostic test by nasal swab or a blood test showing antibodies. And they must be symptom-free for 14 days, with test results, or 28 days without.

The treatment involves collecting plasma, not whole blood. Plasma, the liquid part of the blood, helps with clotting and supports immunity. During the collection, a donor’s blood is put through a machine that collects the plasma only and sends the red blood cells and platelets back to the donor.
 

Clinical trials

Requirements may be more stringent for donors joining a formal clinical trial rather than an expanded access program. For instance, potential donors in a randomized clinical trial underway at Stony Brook University must have higher antibody levels than required by the FDA, says study leader Elliott Bennett-Guerrero, MD, medical director of perioperative quality and patient safety and professor at the Renaissance School of Medicine.

He hopes to enroll up to 500 patients from the Long Island, NY, area. While clinical trials typically have a 50-50 split, with half of subjects getting a treatment and half a placebo, Bennett-Guerrero’s study will give 80% of patients the convalescent plasma and 20% standard plasma.

Julia Sabia Motley, 57, of Merrick, NY, is hoping to become a donor for the Stony Brook study. She and her husband, Sean Motley, 59, tested positive in late March. She has to pass one more test to join the trial. Her husband is also planning to try to donate. “I can finally do something,” Sabia Motley says. Her son is in the MD-PhD program at Stony Brook and told her about the study.
 

Many questions remain

The treatment for COVID-19 is in its infancy. Burk has given the convalescent plasma to two patients. One is now recovering at home, and the other is on a ventilator but improving, he says.

About 200 nationwide have received the therapy, Joyner says. He expects blood supplies to increase as more people are eligible to donate.

Questions remain about how effective the convalescent therapy will be. While experts know that the COVID-19 antibodies “can be helpful in fighting the virus, we don’t know how long the antibodies in the plasma would stay in place,” Bennett-Guerrero says.

Nor do doctors know who the therapy might work best for, beyond people with a severe or life-threatening illness. When it’s been used for other infections, it’s generally given in early stages once someone has symptoms, Joyner says.

Joyner says he sees the treatment as a stopgap ‘’until concentrated antibodies are available.” Several drug companies are working to retrieve antibodies from donors and make concentrated antibody drugs.

“Typically we would think convalescent plasma might be a helpful bridge until therapies that are safe and effective and can be mass-produced are available, such as a vaccine or a drug,” Bennett-Guerrero says.

Even so, he says that he doesn’t think he will have a problem attracting donors, and that he will have repeat donors eager to help.
 

More information for potential donors

Blood banks, the American Red Cross, and others involved in convalescent plasma therapy have posted information online for potential donors. People who don’t meet the qualifications for COVID-19 plasma donations are welcomed as regular blood donors if they meet those criteria

According to the FDA, a donation could potentially help save the lives of up to four COVID-19 patients.

Father Pace is already planning another visit to the blood bank. To pass the time last time, he says, he prayed for the person who would eventually get his blood.

This article first appeared on WebMD.com.

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the spread of COVID-19, is overwhelming for many people. Health care workers in the United States and around the world are leading the battle on the front lines of the pandemic. Thus, they experience a higher level of stress, fear, and anxiety during this crisis.

Over the course of weeks, hospitalists have reviewed articles, attended webinars, and discussed institutional strategies to respond to COVID-19. They follow the most up-to-date clinical information about the approach to patient care, conserving personal protective equipment (PPE), and guidance on how to talk to patients and families during crisis situations. The safety of hospitalists has been underscored with persistent advocacy from multiple organizations, for PPE, access to testing supplies, and decreasing any unnecessary exposure.

While it is agreed that the safety and well-being of hospital medicine teams is crucial to our society’s victory over COVID-19, very little has been discussed with regards to the “hospitalist” well-being and wellness during this pandemic.

The well-being of providers is essential to the success of a health care system. Many hospitalists already experience moral injury and showed evidence of provider burnout before COVID-19. With the onset of the pandemic, this will only get worse and burnout will accelerate if nothing is done to stop it. We cannot wait for the dust to settle to help our colleagues, we must act now.

Many providers have expressed similar pandemic fears, including, uncertainty about screening and testing capability, fear of the PPE shortage, fear of being exposed and underprepared, and fear of bringing the virus home and making family members sick. This list is not exclusive, and there are so many other factors that providers are internally processing, all while continuing their commitment to patient care and safety.

Practicing medicine comes with the heaviest of responsibilities, including the defense of the health of humanity. Therefore, it is easy to understand that, while providers are on the battlefield of this pandemic as they defend the health of humanity, they are not thinking of their own wellness or well-being. Moral injury describes the mental, emotional, and spiritual distress people feel after “perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.” This is already happening, with many hospitals in various cities running out of ventilators, lacking basic supplies for provider safety and leaving providers in survival mode on the front lines without their “suits of armor.” However, many providers will never recognize moral injury or burnout because they are focused on saving as many lives as possible with very limited resources.

While many websites can aid patient and community members on wellness during COVID-19, there is no specific forum or outlet for providers. We must give all hospital medicine team members a multimedia platform to address the fear, anxiety, and uncertainty of COVID-19. We must also provide them with techniques for resilience, coping strategies, and develop a network of support as the situation evolves, in real time.

We must remind hospitalists, “You may be scared, you may feel anxious, and that is okay. It is normal to have these feelings and it is healthy to acknowledge them. Fear serves as an important role in keeping us safe, but if left unchecked it can be horrifying and crippling. However, to conquer it we must face our fears together, with strategy, knowledge, and advocacy. This is the way to rebuild the current health care climate with confidence and trust.”

Although the world may seem foreign and dangerous, it is in adversity that we will find our strength as a hospital medicine community. We go to work every day because that is what we do. Your courage to come to work every day, in spite of any danger that it may present to you, is an inspiration to the world. The battle is not lost, and as individuals and as a community we must build resilience, inspire hope, and empower each other. We are stronger together than we are alone. As hospitalists around the country, and throughout the world, we must agree to uphold the moral integrity of medicine without sacrificing ourselves.
 

Dr. Williams is the vice-president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as the vice-president of the Medical Executive Committee.

Resource

Dean, Wendy; Talbot, Simon; and Dean, Austin. Reframing clinician distress: Moral injury not burnout. Fed Pract. 2019 Sept;36(9):400-2.

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the spread of COVID-19, is overwhelming for many people. Health care workers in the United States and around the world are leading the battle on the front lines of the pandemic. Thus, they experience a higher level of stress, fear, and anxiety during this crisis.

Over the course of weeks, hospitalists have reviewed articles, attended webinars, and discussed institutional strategies to respond to COVID-19. They follow the most up-to-date clinical information about the approach to patient care, conserving personal protective equipment (PPE), and guidance on how to talk to patients and families during crisis situations. The safety of hospitalists has been underscored with persistent advocacy from multiple organizations, for PPE, access to testing supplies, and decreasing any unnecessary exposure.

While it is agreed that the safety and well-being of hospital medicine teams is crucial to our society’s victory over COVID-19, very little has been discussed with regards to the “hospitalist” well-being and wellness during this pandemic.

The well-being of providers is essential to the success of a health care system. Many hospitalists already experience moral injury and showed evidence of provider burnout before COVID-19. With the onset of the pandemic, this will only get worse and burnout will accelerate if nothing is done to stop it. We cannot wait for the dust to settle to help our colleagues, we must act now.

Many providers have expressed similar pandemic fears, including, uncertainty about screening and testing capability, fear of the PPE shortage, fear of being exposed and underprepared, and fear of bringing the virus home and making family members sick. This list is not exclusive, and there are so many other factors that providers are internally processing, all while continuing their commitment to patient care and safety.

Practicing medicine comes with the heaviest of responsibilities, including the defense of the health of humanity. Therefore, it is easy to understand that, while providers are on the battlefield of this pandemic as they defend the health of humanity, they are not thinking of their own wellness or well-being. Moral injury describes the mental, emotional, and spiritual distress people feel after “perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.” This is already happening, with many hospitals in various cities running out of ventilators, lacking basic supplies for provider safety and leaving providers in survival mode on the front lines without their “suits of armor.” However, many providers will never recognize moral injury or burnout because they are focused on saving as many lives as possible with very limited resources.

While many websites can aid patient and community members on wellness during COVID-19, there is no specific forum or outlet for providers. We must give all hospital medicine team members a multimedia platform to address the fear, anxiety, and uncertainty of COVID-19. We must also provide them with techniques for resilience, coping strategies, and develop a network of support as the situation evolves, in real time.

We must remind hospitalists, “You may be scared, you may feel anxious, and that is okay. It is normal to have these feelings and it is healthy to acknowledge them. Fear serves as an important role in keeping us safe, but if left unchecked it can be horrifying and crippling. However, to conquer it we must face our fears together, with strategy, knowledge, and advocacy. This is the way to rebuild the current health care climate with confidence and trust.”

Although the world may seem foreign and dangerous, it is in adversity that we will find our strength as a hospital medicine community. We go to work every day because that is what we do. Your courage to come to work every day, in spite of any danger that it may present to you, is an inspiration to the world. The battle is not lost, and as individuals and as a community we must build resilience, inspire hope, and empower each other. We are stronger together than we are alone. As hospitalists around the country, and throughout the world, we must agree to uphold the moral integrity of medicine without sacrificing ourselves.
 

Dr. Williams is the vice-president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as the vice-president of the Medical Executive Committee.

Resource

Dean, Wendy; Talbot, Simon; and Dean, Austin. Reframing clinician distress: Moral injury not burnout. Fed Pract. 2019 Sept;36(9):400-2.

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the spread of COVID-19, is overwhelming for many people. Health care workers in the United States and around the world are leading the battle on the front lines of the pandemic. Thus, they experience a higher level of stress, fear, and anxiety during this crisis.

Over the course of weeks, hospitalists have reviewed articles, attended webinars, and discussed institutional strategies to respond to COVID-19. They follow the most up-to-date clinical information about the approach to patient care, conserving personal protective equipment (PPE), and guidance on how to talk to patients and families during crisis situations. The safety of hospitalists has been underscored with persistent advocacy from multiple organizations, for PPE, access to testing supplies, and decreasing any unnecessary exposure.

While it is agreed that the safety and well-being of hospital medicine teams is crucial to our society’s victory over COVID-19, very little has been discussed with regards to the “hospitalist” well-being and wellness during this pandemic.

The well-being of providers is essential to the success of a health care system. Many hospitalists already experience moral injury and showed evidence of provider burnout before COVID-19. With the onset of the pandemic, this will only get worse and burnout will accelerate if nothing is done to stop it. We cannot wait for the dust to settle to help our colleagues, we must act now.

Many providers have expressed similar pandemic fears, including, uncertainty about screening and testing capability, fear of the PPE shortage, fear of being exposed and underprepared, and fear of bringing the virus home and making family members sick. This list is not exclusive, and there are so many other factors that providers are internally processing, all while continuing their commitment to patient care and safety.

Practicing medicine comes with the heaviest of responsibilities, including the defense of the health of humanity. Therefore, it is easy to understand that, while providers are on the battlefield of this pandemic as they defend the health of humanity, they are not thinking of their own wellness or well-being. Moral injury describes the mental, emotional, and spiritual distress people feel after “perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.” This is already happening, with many hospitals in various cities running out of ventilators, lacking basic supplies for provider safety and leaving providers in survival mode on the front lines without their “suits of armor.” However, many providers will never recognize moral injury or burnout because they are focused on saving as many lives as possible with very limited resources.

While many websites can aid patient and community members on wellness during COVID-19, there is no specific forum or outlet for providers. We must give all hospital medicine team members a multimedia platform to address the fear, anxiety, and uncertainty of COVID-19. We must also provide them with techniques for resilience, coping strategies, and develop a network of support as the situation evolves, in real time.

We must remind hospitalists, “You may be scared, you may feel anxious, and that is okay. It is normal to have these feelings and it is healthy to acknowledge them. Fear serves as an important role in keeping us safe, but if left unchecked it can be horrifying and crippling. However, to conquer it we must face our fears together, with strategy, knowledge, and advocacy. This is the way to rebuild the current health care climate with confidence and trust.”

Although the world may seem foreign and dangerous, it is in adversity that we will find our strength as a hospital medicine community. We go to work every day because that is what we do. Your courage to come to work every day, in spite of any danger that it may present to you, is an inspiration to the world. The battle is not lost, and as individuals and as a community we must build resilience, inspire hope, and empower each other. We are stronger together than we are alone. As hospitalists around the country, and throughout the world, we must agree to uphold the moral integrity of medicine without sacrificing ourselves.
 

Dr. Williams is the vice-president of the Hampton Roads chapter of the Society of Hospital Medicine. She is a hospitalist at Sentara Careplex Hospital in Hampton, Va., where she also serves as the vice-president of the Medical Executive Committee.

Resource

Dean, Wendy; Talbot, Simon; and Dean, Austin. Reframing clinician distress: Moral injury not burnout. Fed Pract. 2019 Sept;36(9):400-2.

Although priority number one lies in controlling the spread of COVID-19, public health researchers are calling attention to the long-term repercussions of the pandemic on children’s health.

School closures could noticeably worsen the epidemic of childhood obesity that already threatens many children in the United States, say Paul Rundle, DrPH, and colleagues from Columbia University Mailman School of Public Health, New York City, in a perspective published online March 30 in Obesity.

“In part, we wrote the perspective to remind people that summer unhealthy weight gain seems to accumulate year to year,” he told Medscape Medical News in an email.

Rundle and colleagues estimate that time spent out of school will double this year because of school closures due to COVID-19. That, along with shelter-in-place orders, will pose challenges both for physical activity and healthy eating among children.

In addition, playgrounds have closed in many areas, and even where parks remain open, social distancing decreases opportunities for exercise. Team sports are on hold, and without physical education taught in schools, many children will not be getting as much active outdoor play as needed.

That’s especially true for children in urban areas, who may find it even more difficult to exercise inside cramped apartments, they add.

As a result, more and more children may turn to sedentary activities, and increased screen time goes hand in hand with childhood overweight and obesity, not just because of the lack of exercise but also because of snacking on unhealthy, empty-calorie foods while glued to the screen.

“We were hoping to get the word out on this issue, do some education or reminding, and at least let people know that this should be something to keep an eye on, among so many other things,” Rundle added.

Excess Eating Because of Stress and Boredom

Jessica Sparks Lilley, MD, director of the Pediatric Diabetes and Lipid Program at the Mississippi Center for Advanced Medicine in Madison, agrees that it is crucial to address these issues.

“Just like adults, children eat in response to emotions, including stress and boredom, and stress levels are high during these uncertain times,” she told Medscape Medical News.

Although both Rundle and Sparks Lilley acknowledged the challenges of finding good solutions at this time, they do offer some tips.

Schools should make physical education and at-home exercise a priority alongside other remote teaching. Physical education teachers could even stream exercise classes to children at home.

Even just walking in the park while maintaining social distancing could be better than nothing, and a brisk walk is probably even better.

Depending on the age of the child, online yoga may also be useful. Even though yoga burns relatively few calories, it incorporates mindfulness training that may be helpful.

“I think focusing on promoting mindful eating as compared to mindless or distracted eating is important. Even in the best of circumstances, it is hard to exercise enough to burn off high energy snacks,” Rundle said.

Additional Stressors From Poverty: Schools Can Help With Meals

Children living in poverty, already the most vulnerable to obesity and related health problems, have additional stressors, add the two experts.

“As more Americans are losing jobs, poverty is a real threat to many of the children I care for. Families living in poverty often rely on processed, high-calorie, low-nutrient foods for survival, because they are inexpensive and shelf-stable,” Sparks Lilley said.

Rundle and colleagues agree: “Our own experiences in supermarkets show...shelves that held...crackers, chips, ramen noodles, soda, sugary cereals, and processed ready-to-eat meals are quite empty. We anticipate that many children will experience higher calorie diets during the pandemic response.”

Similar to how they address food insecurity during summer holidays, school districts have responded by offering grab-and-go meals, Rundle and colleagues note.

To maintain social distancing for people with vulnerable family members, some school districts have also started delivering food using school buses that run along regularly scheduled routes.

Rundle also stresses that farmers’ markets, which often provide foods that appeal to immigrant and ethnic communities, should be considered part of essential food services.

As such, social distancing protocols should be established for them and they should be allowed to stay open, he argues.

“The safety of American children is at stake in many ways. The threat to themselves or their caregivers being infected with COVID-19 is rightly foremost in our concerns,” Sparks Lilley stressed.

“However, there is other fallout to consider. We’ve seen very clearly the need for public health and preventive medicine and can’t let vulnerable children fall through the cracks.”

Rundle agrees. Although it is a “priority” to mitigate the immediate impact of COVID-19, “it is important to consider ways to prevent its long-term effects, including new risks for childhood obesity.”

Rundle and coauthors, as well as Sparks Lilley, have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Although priority number one lies in controlling the spread of COVID-19, public health researchers are calling attention to the long-term repercussions of the pandemic on children’s health.

School closures could noticeably worsen the epidemic of childhood obesity that already threatens many children in the United States, say Paul Rundle, DrPH, and colleagues from Columbia University Mailman School of Public Health, New York City, in a perspective published online March 30 in Obesity.

“In part, we wrote the perspective to remind people that summer unhealthy weight gain seems to accumulate year to year,” he told Medscape Medical News in an email.

Rundle and colleagues estimate that time spent out of school will double this year because of school closures due to COVID-19. That, along with shelter-in-place orders, will pose challenges both for physical activity and healthy eating among children.

In addition, playgrounds have closed in many areas, and even where parks remain open, social distancing decreases opportunities for exercise. Team sports are on hold, and without physical education taught in schools, many children will not be getting as much active outdoor play as needed.

That’s especially true for children in urban areas, who may find it even more difficult to exercise inside cramped apartments, they add.

As a result, more and more children may turn to sedentary activities, and increased screen time goes hand in hand with childhood overweight and obesity, not just because of the lack of exercise but also because of snacking on unhealthy, empty-calorie foods while glued to the screen.

“We were hoping to get the word out on this issue, do some education or reminding, and at least let people know that this should be something to keep an eye on, among so many other things,” Rundle added.

Excess Eating Because of Stress and Boredom

Jessica Sparks Lilley, MD, director of the Pediatric Diabetes and Lipid Program at the Mississippi Center for Advanced Medicine in Madison, agrees that it is crucial to address these issues.

“Just like adults, children eat in response to emotions, including stress and boredom, and stress levels are high during these uncertain times,” she told Medscape Medical News.

Although both Rundle and Sparks Lilley acknowledged the challenges of finding good solutions at this time, they do offer some tips.

Schools should make physical education and at-home exercise a priority alongside other remote teaching. Physical education teachers could even stream exercise classes to children at home.

Even just walking in the park while maintaining social distancing could be better than nothing, and a brisk walk is probably even better.

Depending on the age of the child, online yoga may also be useful. Even though yoga burns relatively few calories, it incorporates mindfulness training that may be helpful.

“I think focusing on promoting mindful eating as compared to mindless or distracted eating is important. Even in the best of circumstances, it is hard to exercise enough to burn off high energy snacks,” Rundle said.

Additional Stressors From Poverty: Schools Can Help With Meals

Children living in poverty, already the most vulnerable to obesity and related health problems, have additional stressors, add the two experts.

“As more Americans are losing jobs, poverty is a real threat to many of the children I care for. Families living in poverty often rely on processed, high-calorie, low-nutrient foods for survival, because they are inexpensive and shelf-stable,” Sparks Lilley said.

Rundle and colleagues agree: “Our own experiences in supermarkets show...shelves that held...crackers, chips, ramen noodles, soda, sugary cereals, and processed ready-to-eat meals are quite empty. We anticipate that many children will experience higher calorie diets during the pandemic response.”

Similar to how they address food insecurity during summer holidays, school districts have responded by offering grab-and-go meals, Rundle and colleagues note.

To maintain social distancing for people with vulnerable family members, some school districts have also started delivering food using school buses that run along regularly scheduled routes.

Rundle also stresses that farmers’ markets, which often provide foods that appeal to immigrant and ethnic communities, should be considered part of essential food services.

As such, social distancing protocols should be established for them and they should be allowed to stay open, he argues.

“The safety of American children is at stake in many ways. The threat to themselves or their caregivers being infected with COVID-19 is rightly foremost in our concerns,” Sparks Lilley stressed.

“However, there is other fallout to consider. We’ve seen very clearly the need for public health and preventive medicine and can’t let vulnerable children fall through the cracks.”

Rundle agrees. Although it is a “priority” to mitigate the immediate impact of COVID-19, “it is important to consider ways to prevent its long-term effects, including new risks for childhood obesity.”

Rundle and coauthors, as well as Sparks Lilley, have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Although priority number one lies in controlling the spread of COVID-19, public health researchers are calling attention to the long-term repercussions of the pandemic on children’s health.

School closures could noticeably worsen the epidemic of childhood obesity that already threatens many children in the United States, say Paul Rundle, DrPH, and colleagues from Columbia University Mailman School of Public Health, New York City, in a perspective published online March 30 in Obesity.

“In part, we wrote the perspective to remind people that summer unhealthy weight gain seems to accumulate year to year,” he told Medscape Medical News in an email.

Rundle and colleagues estimate that time spent out of school will double this year because of school closures due to COVID-19. That, along with shelter-in-place orders, will pose challenges both for physical activity and healthy eating among children.

In addition, playgrounds have closed in many areas, and even where parks remain open, social distancing decreases opportunities for exercise. Team sports are on hold, and without physical education taught in schools, many children will not be getting as much active outdoor play as needed.

That’s especially true for children in urban areas, who may find it even more difficult to exercise inside cramped apartments, they add.

As a result, more and more children may turn to sedentary activities, and increased screen time goes hand in hand with childhood overweight and obesity, not just because of the lack of exercise but also because of snacking on unhealthy, empty-calorie foods while glued to the screen.

“We were hoping to get the word out on this issue, do some education or reminding, and at least let people know that this should be something to keep an eye on, among so many other things,” Rundle added.

Excess Eating Because of Stress and Boredom

Jessica Sparks Lilley, MD, director of the Pediatric Diabetes and Lipid Program at the Mississippi Center for Advanced Medicine in Madison, agrees that it is crucial to address these issues.

“Just like adults, children eat in response to emotions, including stress and boredom, and stress levels are high during these uncertain times,” she told Medscape Medical News.

Although both Rundle and Sparks Lilley acknowledged the challenges of finding good solutions at this time, they do offer some tips.

Schools should make physical education and at-home exercise a priority alongside other remote teaching. Physical education teachers could even stream exercise classes to children at home.

Even just walking in the park while maintaining social distancing could be better than nothing, and a brisk walk is probably even better.

Depending on the age of the child, online yoga may also be useful. Even though yoga burns relatively few calories, it incorporates mindfulness training that may be helpful.

“I think focusing on promoting mindful eating as compared to mindless or distracted eating is important. Even in the best of circumstances, it is hard to exercise enough to burn off high energy snacks,” Rundle said.

Additional Stressors From Poverty: Schools Can Help With Meals

Children living in poverty, already the most vulnerable to obesity and related health problems, have additional stressors, add the two experts.

“As more Americans are losing jobs, poverty is a real threat to many of the children I care for. Families living in poverty often rely on processed, high-calorie, low-nutrient foods for survival, because they are inexpensive and shelf-stable,” Sparks Lilley said.

Rundle and colleagues agree: “Our own experiences in supermarkets show...shelves that held...crackers, chips, ramen noodles, soda, sugary cereals, and processed ready-to-eat meals are quite empty. We anticipate that many children will experience higher calorie diets during the pandemic response.”

Similar to how they address food insecurity during summer holidays, school districts have responded by offering grab-and-go meals, Rundle and colleagues note.

To maintain social distancing for people with vulnerable family members, some school districts have also started delivering food using school buses that run along regularly scheduled routes.

Rundle also stresses that farmers’ markets, which often provide foods that appeal to immigrant and ethnic communities, should be considered part of essential food services.

As such, social distancing protocols should be established for them and they should be allowed to stay open, he argues.

“The safety of American children is at stake in many ways. The threat to themselves or their caregivers being infected with COVID-19 is rightly foremost in our concerns,” Sparks Lilley stressed.

“However, there is other fallout to consider. We’ve seen very clearly the need for public health and preventive medicine and can’t let vulnerable children fall through the cracks.”

Rundle agrees. Although it is a “priority” to mitigate the immediate impact of COVID-19, “it is important to consider ways to prevent its long-term effects, including new risks for childhood obesity.”

Rundle and coauthors, as well as Sparks Lilley, have reported no relevant financial relationships.

This article first appeared on Medscape.com.

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

A consensus statement on the role of imaging during the acute work-up of COVID-19 patients called for liberal use in patients with moderate to severe clinical features indicative of infection, regardless of their COVID-19 test results, but limited use in patients who present with mild symptoms or are asymptomatic.

The consensus statement on The Role of Imaging in Patient Management during the COVID-19 Pandemic released by the Fleischner Society on April 7 was designed to highlight the “key decision points around imaging” in COVID-19 patients.

“We developed the statement to be applicable across settings” so that each clinic or hospital managing COVID-19 patients could decide the situations where chest radiography (CXR) or CT would work best, said Geoffrey D. Rubin, MD, professor of cardiovascular research, radiology, and bioengineering at Duke University in Durham, N.C., and lead author of the statement.

Written by 15 thoracic radiologists and 10 pulmonologists/intensivists including an anesthesiologist, a pathologist, and additional experts in emergency medicine, infection control, and laboratory medicine, and with members from any of 10 countries on three continents, the panel arrived at agreement by more than 70% for each of the 14 questions.

“I was impressed and a little surprised that consensus was achieved for every question” posed to the panel by the Fleischner Society for Thoracic Imaging and Diagnosis, Dr. Rubin said in an interview. The panel also placed their 14 decisions about imaging within the context of three distinct clinical scenarios chosen to mirror common real-world situations: mild COVID-19 features, moderate to severe features with no critical-resource constraints, and moderate to severe features with constrained resources. The statement also summarized its conclusions as five main recommendations and three additional recommendations.
 

Main recommendations

• Imaging is not routinely indicated for COVID-19 screening in asymptomatic people.
• Imaging is not indicated for patients with mild features of COVID-19 unless they are at risk for disease progression.
• Imaging is indicated for patients with features of moderate to severe COVID-19 regardless of COVID-19 test results.
• Imaging is indicated for patients with COVID-19 and evidence of worsening respiratory status.
• When access to CT is limited, chest radiography may be preferred for COVID-19 patients unless features of respiratory worsening warrant using CT.

Additional recommendations

• Daily chest radiographs are not indicated in stable, intubated patients with COVID-19.
• CT is indicated in patients with functional impairment, hypoxemia, or both, after COVID-19 recovery.
• COVID-19 testing is warranted in patients incidentally found to have findings suggestive of COVID-19 on a CT scan.

The statement particularly called out one of its recommendations – that a COVID-19 diagnosis “may be presumed when imaging findings are strongly suggestive of COVID-19 despite negative COVID-19 testing” in a patient who has moderate to severe clinical features of COVID-19 and whose pretest probability is high. The panel voted unanimously in favor of this concept, that imaging is “indicated” in hospitalized patients with moderate to severe symptoms consistent with COVID-19 despite a negative COVID-19 test result. “This guidance represents variance from other published recommendations which advise against the use of imaging for the initial diagnosis of COVID-19,” the statement acknowledged and specifically cited the recommendations issued in March 2020 by the American College of Radiology. Despite that, the ACR and Fleischner recommendations “are not at odds with one another,” maintained Dr. Rubin. The panel based its take on this question on the “direct experience” of its members caring for COVID-19 patients, according to the statement.

“I wholeheartedly agree with the suggested uses of imaging outlined by the panel,” commented Sachin Gupta, MD, FCCP, a pulmonologist and critical care physician in San Francisco. “The consensus statement brings a practical way to consider obtaining imaging. It leaves the door open to local standards and best judgment for using CXR or CT. Many physicians are unclear whether to image low-risk and mildly symptomatic patients. This statement gives support to a watchful waiting approach.” Another recommendation advises against daily CXR in stable, intubated COVID-19 patients. This “now gives backing from an important society and thought leaders while giving an explanation” for why daily imaging is problematic, he noted in an interview. The daily CXR in these patients adds no value, and skipping unneeded imaging minimizes SARS-CoV-2 exposure to radiology personnel, and conserves personal protection equipment, said the statement.

“The Fleischner Society is known worldwide for its recommendations. Having the society lend its weight on triage with imaging for COVID-19 patients is important. I suspect it will help standardize practice.”

Dr. Gupta also highlighted that lung imaging with a portable ultrasound unit has quickly become recognized as a very useful imaging tool with increasing use as the pandemic has unfolded, an option not covered by the Fleischner statement. Study results have “confirmed excellent sensitivity, specificity, and reproducibility” with lung ultrasound, and it’s also “easy to use,” Dr. Gupta said.

Ultrasound chest imaging of COVID-19 patients did not get included in the statement despite the reliance some U.S. sites have already placed on it largely because few on the panel had direct experience using it. “We didn’t feel we could contribute” to a discussion of ultrasound, Dr. Rubin said.

The statement’s recommendations appear to have already begun influencing practice. “The feedback I’ve gotten is that people are relying on them,” said Dr. Rubin, and some programs have sent him screen shots of the recommendations embedded in their local electronic health record.

The Radiological Society of North America is hosting a webinar on the statement on April 17.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

Patients infected by the COVID-19 virus may benefit from treatments that dampen the renin-angiotensin system, according to a review of several animal studies. These preclinical findings generally support the positions taken in recent week by several cardiology societies that recommended patients taking drugs that moderate the renin-angiotensin system stay on these treatments.

“In patients with cardiovascular disease and SARS-CoV2, the use of ACE inhibitors, ARBs [angiotensin receptor blockers], or MRAs [mineralocorticoid-receptor antagonists] may be favorable as a method to endogenously upregulate ACE2 as a compensatory mechanism that provides anti-inflammatory, antifibrotic, and antithrombotic support as well as reduction in progression of vascular/cardiac remodeling and heart failure,” wrote Jeffrey Bander, MD, and his associates in a report published online (J Am Coll Cardiol. 2020 Apr 15. doi: 10.1016/j.jacc.2020.04.028).

“Based on our review, we hypothesize cardiovascular patients with COVID-19 should remain on RAS [renin-angiotensin system] inhibitors given the protective effects of the ACE2 pathway until RAS blockade is proven to increase the risk to COVID-19,” said the researchers, who are affiliated with the Icahn School of Medicine at Mount Sinai in New York.

The ACE2 protein, found both in human blood as well as in cell membranes, especially cells of the lungs, heart, kidneys, and gastrointestinal tissues, functions as both a key enzyme in RAS regulation as well as the primary cell receptor for entry of SARS-CoV2.

Their conclusion jibed with both a joint statement in March from the American College of Cardiology, American Heart Association, and the Heart Failure Society of America; and with the conclusions of a review organized by the European Society of Hypertension’s COVID-19 Task Force (Cardiovasc Res. 2020 Apr 15. doi: 10.1093/cvr/cvaa097).

In their review, the Mount Sinai authors described results from several animal studies suggesting that ACE2 and its associated signaling proteins could potentially be a “valuable therapeutic target.” They also highlighted several clinical intervention studies recently launched to target ACE2, related proteins, and regulation of this arm of the RAS.

Currently, “no data support any conclusive effects of the use of RAS inhibitors in patients with COVID-19,” they concluded. They acknowledged that “the question remains whether the use of ACE inhibitors, ARBs, and MRAs should be avoided in the setting of SARS-CoV infection,” but emphasized that “adequate data on the effects of RAS inhibition in COVID-19 patients is not available,” with more data becoming available soon from ongoing clinical studies.

None of the authors had any disclosures.

[email protected]

People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.

Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.

The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.

The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).

“Future research should examine biological factors that may explain the COPD-depression relationship and in particular, smoking as an interaction, as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”

No disclosures or conflicts of interest were reported.

[email protected]

SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
 

People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.

Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.

The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.

The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).

“Future research should examine biological factors that may explain the COPD-depression relationship and in particular, smoking as an interaction, as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”

No disclosures or conflicts of interest were reported.

[email protected]

SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
 

People with chronic obstructive pulmonary disorder (COPD) and those who smoke are at an increased risk of developing depression, results of a population-based cohort study of more than 3 million patients show.

Using data from the Veterans Affairs Corporate Data Warehouse, Natalie B. Riblet, MD, MPH, and colleagues conducted the study on 3,284,496 patients who accessed VA health care during 2004-2014 and had a negative depression screen. About 95% of this population was male, 83.4% were white, and the average age was 61.3 years. Just under 40,000 people were patients with COPD, reported Dr. Riblet, of the Veterans Affairs Medical Center in White River Junction, Vt., and the Geisel School of Medicine at Dartmouth, Hanover, N.H. The study was published in General Hospital Psychiatry.

The investigators found that current, former, and never smokers were split fairly evenly at 32.1%, 32.4%, and 30.3% of the total study population, respectively. Of those with COPD, 53.6% were current smokers, 27% were former smokers, and 11.6% were never smokers.

The odds of developing depression in a year were 2.3%, 1.5%, and 1.4% in current, former, and never smokers without COPD, respectively; for those with COPD, the odds were 2.9%, 2.2%, and 2% for current, former, and never smokers, respectively. Overall, the odds ratio of patients with COPD developing depression, compared with those without COPD, was 1.57 (95% confidence interval, 1.54-1.61). Current smokers also were at an increased risk, compared with never smokers (OR, 1.83; 95% CI, 1.81-1.85), though the effect was somewhat mitigated after adjusting for confounders (OR, 1.56; 95% CI, 1.55-1.58).

“Future research should examine biological factors that may explain the COPD-depression relationship and in particular, smoking as an interaction, as this may guide the development and implementation of new treatments for depression in the COPD population,” the investigators concluded. “If COPD-related depression is due, at least in part, to adverse physiological effects related to chronic hypoxia, these patients may require new or more tailored interventions.”

No disclosures or conflicts of interest were reported.

[email protected]

SOURCE: Riblet NB et al. Gen Hosp Psychiatry. 2020 May-Jun;64:72-9.
 

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Mass social distancing and social isolation to prevent the spread of a deadly disease, along with technological tools that allow social communication and continued work and school, is an unprecedented situation.

Stockbyte/Thinkstock.com

The current reality of most people’s lives during the COVID-19 pandemic has the potential to induce or exacerbate sleep problems, though it may also present some with an opportunity to improve sleep, wrote Ellemarije Altena, PhD, of the University of Bordeaux (France), and her colleagues in a recent research review in the Journal of Sleep Research.

The review was conducted by a task force of the European Academy for Cognitive Behavioural Therapy for Insomnia. The European CBT-I Academy is an initiative of the European Insomnia Network to promote implementation and dissemination of treatment.

After discussing the known effects of stress, confinement, and altered schedules on sleep, the authors present recommendations on ways to manage sleep problems such as insomnia in the general public and potentially encourage people to take advantage of the opportunity to align their schedules with their natural circadian rhythms. Physicians may find the recommendations helpful in advising patients with sleep problems related to the COVID-19 emergency.

“Being forced to stay at home, work from home, do homeschooling with children, drastically minimize outings, reduce social interaction or work many more hours under stressful circumstances, and in parallel manage the attendant health risks, can have a major impact on daily functioning and nighttime sleep,” Dr. Altena and colleagues wrote.

There may also be a lag time in physicians hearing about changes in sleep or sleeping problems from patients, said Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah in Salt Lake City. “There may actually be some improvement in sleep durations given that most folks are working from home with more time with family and less work-related stress,” he said in an interview. “In terms of sleep or other effects on worsening of psychiatric problems, it is still not clear what the overall effects are going to be.”

Although daylight has the biggest impact on regulating circadian rhythms, artificial light, meal times, diet, and amount of physical activity can also have an influence. Negative effects on sleep can result from both excessively high activity levels, such as stress and work overload, or excessively low levels, such as from depression or confinement, the authors note.

The current situation also opens the door to interactions between stress, sleep, anxiety, and risk of PTSD. “Those sensitive to stress-related sleep disruption are more likely to develop chronic insomnia,” which, in combination with a major stressor, is a risk factor for PTSD, the authors write. They note that 7% of Wuhan residents, the city in China where the virus appears to have originated, particularly women, reported PTSD symptoms after the COVID-19 outbreak, and anxiety was highest in those under age 35 years and those who followed news about the disease for more than 3 hours a day.

Better sleep quality and fewer early morning awakenings, however, appeared to be protective against PTSD symptoms. The authors note the value of physical exercise, cognitive interventions, and relaxation techniques, including meditation, for reducing stress and milder symptoms of PTSD.

“Some patients are sleeping a bit better because of the pace of things has slowed down a bit,” said Anne C. Trainor, a nurse practitioner and instructor in the neurology department’s sleep disorders program at Oregon Health & Science University in Portland, who was not involved in the study. “Keeping a regular schedule for sleeping and eating, getting exercise daily – preferably in sunlight and not just before bedtime – and using relaxation or mindfulness practice and cognitive interventions to help manage anxiety” were the key takeaways from this review, Ms. Trainor said in an interview.


 

Home confinement, stressors and sleep

A wide range of stressors could affect sleep during COVID-19 social distancing interventions, including “major changes in routines, living with uncertainty,” and anxiety about health, the economic situation, and how long this situation will last, the authors write.

Parents must juggle work, homeschooling, and ordinary household errands and management. Meanwhile, entrepreneurs, small business owners ,and workers in entertainment, hospitality and food service must contend with anxiety about job uncertainty and financial security. For anyone working from home, disruptions to work and home routines can make it difficult to associate being home with relaxation – and sleep.

“The more regular our sleep schedule is the better quality our sleep tends to be, but it is a struggle when we don’t have separate spaces to work and parent in,” Ms. Trainor said.

At the same time, “confinement-related stress may be caused by an inability to engage in rewarding activities, such as visiting friends and family, shopping, attending cultural and sports events, and visiting bars or restaurants,” the authors write. “Spending more time with family in a limited space can also induce stress, particularly in situations where there are preexisting family difficulties.”

Being stuck at home may lead to less daylight exposure than usual, reduced physical activity, and increased eating, which can contribute to weight gain and other health risks. However, “the effect of stress from confinement, loss of work, and health concerns needs to be individualized and may be difficult to generalize,” Dr. Sundar said.

The authors of the review note the established associations between too little social interaction, increased stress, and poor sleep quality, though loneliness mediates this relationship. Loneliness is also a risk during this time, with or without online social interaction.

Children and teens may also have difficulty sleeping, which can affect their behavioral and emotional regulation, and primary caregivers experience more stress while juggling childcare, household duties, and work.

“While many parents share childcare and household responsibilities, in most families these tasks are still predominantly managed by mothers,” the authors added.

“Sharing responsibilities between parents and not overworking just one parent is key,” said Brandon M. Seay MD, a pediatric pulmonologist and sleep specialist at Children’s Healthcare of Atlanta. He also recommended trying to incorporate work into the day while kids are doing online learning.

Ms. Trainor agreed that trading off responsibilities between parents is ideal, though the challenge is greater for single parents. It may be possible for some to take family leave, but not all families have that option, she said.

The study authors also point out a Catch-22 for many people: The blurred boundary between home life and work life can undermine work productivity and efficiency, thereby increasing stress. “Healthy sleep may be a key protective factor to cope positively with these challenges, although adequate opportunity to sleep may be affected by increased time pressure of work, childcare, and household requirements.”

Dr. Seay advises adults to try to get at least 6-8 hours of sleep each night, even taking advantage of a later waking time – if the kids also sleep in – to help. “If anything, the ability to sleep later and wake up later is of benefit for a lot of my teenage patients,” he said in an interview.

In fact, the study authors also address possible positive effects on sleep for some people during the current situation. Since social support can improve sleep quality, social media interaction might provide some social support, though it’s not the same as meeting people in person and “screen exposure may hamper sleep quality when used close to bedtime.”

Some people may actually have an opportunity to get more daylight exposure or exercise, which can improve sleep, and some, especially night owls and teenagers, may be able to align their daily schedules more closely to their natural circadian rhythms.

“Given that we are not bound by usual work or social schedules, there may be a tendency to drift to our sleep chronotypes,” especially for teenagers, Dr. Sundar said.

For some, this may be their first opportunity to learn what their chronotype is, Dr. Seay said.

“It is always advantageous to ‘obey’ your natural sleep timing, [although] it simply isn’t always the most efficient outside of our current situation,” he said. “Use this as a time to figure out your natural sleep timing if you constantly have issues being able to wake up in the morning. Now that you don’t have to be up for work or school, you can figure out what time works for you.”

At the same time, if you have an extreme circadian rhythm disorder, especially an irregular one, it may still be best to try to keep a regular sleep schedule to avoid feeling isolated if others are socializing while you’re asleep, Ms. Trainor said.

The authors similarly note the limits of potential benefits during this time, noting that they “may not be enough to counteract the negative effects of the increased work and family requirements, as well as the overwhelming levels of stress and anxiety about the well-being of oneself and others, and the negative effects of confinement for family social reactions.”
 

Treating stress, anxiety, and insomnia

The first-line treatment for chronic insomnia is cognitive-behavioral therapy for insomnia, but “recent evidence shows that cognitive-behavioral therapy can also serve to treat sudden-onset (acute) insomnia due to rapid stress-causing situation changes,” the authors noted. They also reviewed the key elements of CBT-I: stimulus control, sleep hygiene, relaxation interventions, cognitive reappraisal, paradoxical intention, and sleep restriction.

CBT-I lends very naturally to telemedicine, Dr. Seay, Dr. Sundar, and Ms. Trainor all agreed.

“I actually see this current situation as an opportunity for health care practices and providers to expand the reach of telemedicine – due to necessity – which will hopefully continue after confinement has been lifted worldwide,” Dr. Seay said.  

Dr. Sundar pointed to research supporting CBT-I online and several apps that can be used for it, such as SHUTi and Sleepio. Ms. Trainor noted that the Cleveland Clinic offers a basic CBT-I online class for $40.

The authors note that prescribing medication is generally discouraged because it lacks evidence for long-term effectiveness of chronic insomnia, but it might be worth considering as a second-line therapy for acute insomnia from outside stressors, such as home confinement, if CBT-I doesn’t work or isn’t possible. Pharmacologic treatment can include benzodiazepines, hypnotic benzodiazepine receptor agonists, or sedating antidepressants, particularly if used for a comorbid mood disorder.

The authors then offer general recommendations for improving sleep that doctors can pass on to their patients:

• Get up and go to bed at approximately the same times daily.
• Schedule 15-minute breaks during the day to manage stress and reflect on worries and the situation.
• Reserve the bed for sleep and sex only; not for working, watching TV, using the computer, or doing other activities.
• Try to follow your natural sleep rhythm as much as possible.
• Use social media as stress relief, an opportunity to communicate with friends and family, and distraction, especially with uplifting stories or humor.
• Leave devices out of the bedroom.
• Limit your exposure to news about the COVID-19 pandemic.
• Exercise regularly, ideally in daylight.
• Look for ways to stay busy and distracted, including making your home or bedroom more comfortable if possible.
• Get as much daylight during the day as possible, and keep lights dim or dark at night.
• Engage in familiar, comfortable, relaxing activities before bedtime.
• If your daily activity level is lower, eat less as well, ideally at least 2 hours before going to bed.

The authors also offered recommendations specifically for families:

• Divide child care, home maintenance, and chores between adults, being sure not to let the lion’s share fall on women.
• Maintain regular sleep times for children and spend the 30 minutes before their bedtime doing a calming, familiar activity that both the children and parents enjoy.
• “While using computer, smartphones, and watching TV more than usual may be inevitable in confinement, avoid technological devices after dinner or too close to bedtime.”
• Ensure your child has daily physical activity, keep a relatively consistent schedule or routine, expose them to as much daylight or bright light as possible during the day, and try to limit their bed use only to sleeping if possible. “Parents need to be involved in setting schedules for sleep and meal times so that kids do not get into sleep patterns that are difficult to change when school starts back,” Dr. Sundar said. “Limiting screen time is also important especially during nighttime.”
• Reassure children if they wake up anxious at night.

SOURCE: Altena E et al. J Sleep Res. 2020 Apr 4. doi: 10.1111/jsr.13052.

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.
 

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.
 

Hydroxychloroquine (HCQ) does not help clear the SARS-CoV-2 virus or relieve symptoms for COVID-19 patients more than standard care alone and has more side effects, a randomized controlled trial of 150 hospitalized adults in China suggests.

However, two experts caution that, because of confounding, the trial is unable to answer convincingly the question of whether HCQ can benefit COVID-19 patients.

Wei Tang, with the Departments of Pulmonology and Critical Care Medicine at Ruijin Hospital, in Shanghai, China, and colleagues enrolled patients with COVID-19 from 16 treatment centers in China in February. They posted their findings on the medRxiv preprint server, but their paper has not been peer reviewed. A coauthor told Medscape Medical News the work has been submitted to a journal.

The overall 28-day negative conversion rate of SARS-CoV-2, which was the primary endpoint, was similar in the two 75-patient treatment groups. The Kaplan-Meier estimate for negative conversion rate was 85.4% in the HCQ plus standard of care (SOC) arm, vs 81.3% in the SOC-only group (P = .341). Negative conversion rates for the two groups were similar at days 4, 7, 10, 14, and 21.

Adverse events were reported in 8.8% of patients in the control group compared with 30% in the HCQ group. Diarrhea was the most common side effect, occurring in 10% of patients in the HCQ group vs none in the control group. Two patients in the HCQ arm had serious adverse events; one experienced disease progression, and the other experienced upper respiratory tract infection.

Patients in the HCQ group received a high loading dose of 1200 mg daily for 3 days followed by a maintenance dose of 800 mg daily for the remaining days. Total duration was 2 weeks for patients with mild or moderate disease and 3 weeks for those with severe disease.

No Difference in Relief of Symptoms

The two arms were similar in alleviation of symptoms by day 28: 59.9% with HCQ plus SOC vs 66.6% with SOC alone.

However, the researchers said that in a post hoc analysis, they found a significant reduction of symptoms after adjusting for the confounding effects of antiviral agents (hazard ratio, 8.83; 95% confidence interval, 1.09 – 71.3).

In addition, Tang and colleagues report a significantly greater reduction of C-reactive protein (CRP), a biomarker for inflammation, from baseline to day 28 in the HCQ group in comparison with the control group (6.986 vs 2.723 mg/L).

The authors suggest the alleviation of symptoms may come from HCQ’s anti-inflammatory effects.

The mean age of the patients was 46 years, and 55% were male. Almost all patients had mild or moderate disease; two had severe disease.

Experts Say Study Arms May Not Have Been Comparable

J. Michelle Kahlenberg, MD, PhD, research professor of rheumatology at the University of Michigan in Ann Arbor, told Medscape Medical News that it’s important to note that in the post hoc analysis, 89% of the patients in this trial were receiving other therapy in addition to HCQ.

“When [the researchers] say they saw improvement in symptoms when they removed the confounders, what they actually did was remove the patients from the analysis that got antivirals, and that left 14 patients in each arm,” Kahlenberg said.

Moreover, Kahlenberg noted, 20% of patients who received HCQ had mild symptoms, whereas only 9% of those in the SOC group did.

“We don’t know how those patients played out in the post hoc analysis — whether it was the patients who were really mild that didn’t get the antivirals that were left in the hydroxychloroquine group and that’s why they had a slightly faster resolution of symptoms,” she said.

She said that in this study, the researchers calculated CRP in milligrams per liter, whereas in the United States, it is measured in milligrams per deciliter. The conversion highlights the fact that the reduction in CRP was not terribly noteworthy, she said.

“The patients with COVID who tend to tank and have cytokine storms ― their CRP is much higher,” she said. “So the small improvement in CRP wasn’t that exciting.

“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.

Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.

Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.

For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.

“It makes me wonder whether the randomization was truly random,” Plowe said.

Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.

“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.

Mixed Results in Other Studies

“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.

However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.

Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.

By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.

The work was supported by the Emergent Projects of National Science and Technology; the National Natural Science Foundation of China; the National Key Research and Development Program of China; the Shanghai Municipal Key Clinical Specialty; the National Innovative Research Team of High-Level Local Universities in Shanghai; the Shanghai Key Discipline for Respiratory Diseases; the National Major Scientific and Technological Special Project for Significant New Drugs Development; and Key Projects in the National Science and Technology Pillar Program. The authors, Kahlenberg, and Plowe have disclosed no relevant financial relationships.

This story first appeared on Medscape.com.