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Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

The novel coronavirus (2019-nCoV) is presenting a severe challenge to global health care, but its impact isn’t just felt in the emergency department. Specialists, including dermatologists, must also navigate the presence of the virus and its impact on patients and practices.

Courtesy CDC

A new report from dermatologists in China’s Wuhan province, where the 2019-nCoV outbreak began, outlines initial experiences and provides a blueprint for triaging potential cases before they reach the dermatology clinic. Despite its presence in the epicenter of the outbreak, the hospital has not detected any 2019-nCoV-infected patients in any of its departments.

The commentary appeared in the British Journal of Dermatology and was authored by a group led by Juan Tao of Huazhong University of Science and Technology (Br J Dermatol. 2020 Mar 5. doi: 10.1111/bjd.19011).

The hospital triages all patients at the hospital entrance. Those who are suspected of having 2019-nCoV infection are sent to a designated department. Those with a skin condition who are not suspected of being infected are allowed to go to a dermatology triage center, where they are examined again. If the second examination raises suspicion, they are sent to the designated 2019-nCoV department. If no infection is suspected, or a patient from the 2019-nCoV department is cleared, they are allowed access to the dermatology clinic.

The team also suggested that skin lesions associated with dermatological conditions could lead to increased risk of 2019-nCoV infection. Contacted by email, Dr. Tao outlined a theoretical risk that the virus could lead to infection through contact with subcutaneous tissues, mucosal surfaces, or blood vessels. He did not respond to a request for evidence that such a route of transmission had occurred.

However, Adam Friedman, MD, professor of dermatology at George Washington University, Washington, said he doubted any such transmission would occur since the virus does not infect keratinocytes, and expressed concern that the suggestion could add to the stigma experienced by dermatological patients, whose noticeable rashes can sometimes lead to social avoidance. “I don’t want to add to that,” said Dr. Friedman in an interview.

A critical aspect of dermatology is the immunosuppressive agents often used in dermatology patients. Such drugs could make them more susceptible to infections, or to worse outcomes in the event of disease. Dr. Friedman recounted sending a letter to one patient on an immunosuppressive medication, suggesting that she work remotely. “I think that’s something we have to think about in at-risk individuals. I know there’s such a focus on the elderly, but there’s a large population of individuals on medications that lower their immune system who are going to be at risk for more severe infections,” said Dr. Friedman.

To reduce patient exposure, the commentary recommended that dermatologists perform online consultation for mild and nonemergency cases.

The authors also covered hospitalized patients with primary or secondary skin conditions. A dermatologist is on site at the dermatology triage station to conduct in-depth assessments if needed. If a patient has a fever that is believed to be caused by a dermatologic condition, the on-site dermatologist assists in the consult.

Because some patients may only become symptomatic after admission to a ward, the authors recommend hospitals have a COVID-19 trained contingency group on hand to prevent and control outbreaks within the institution. The team should be in communication with respiratory intensive care and radiology departments to exclude 2019-nCoV when cases develop in-hospital, and to ensure proper care infected patients who require it.

When a hospitalized 2019-nCoV-infected patient has a skin condition requiring treatment, the authors recommend that pictures be sent to the dermatologist for evaluation, along with teleconferences to further assess the patient. If necessary, the dermatologist should go to the patient’s bedside, with as much information as possible related in advance in order to minimize bedside exposure.

There was no funding source. Dr. Tao and Dr. Friedman have no relevant financial conflicts.

The novel coronavirus (2019-nCoV) is presenting a severe challenge to global health care, but its impact isn’t just felt in the emergency department. Specialists, including dermatologists, must also navigate the presence of the virus and its impact on patients and practices.

Courtesy CDC

A new report from dermatologists in China’s Wuhan province, where the 2019-nCoV outbreak began, outlines initial experiences and provides a blueprint for triaging potential cases before they reach the dermatology clinic. Despite its presence in the epicenter of the outbreak, the hospital has not detected any 2019-nCoV-infected patients in any of its departments.

The commentary appeared in the British Journal of Dermatology and was authored by a group led by Juan Tao of Huazhong University of Science and Technology (Br J Dermatol. 2020 Mar 5. doi: 10.1111/bjd.19011).

The hospital triages all patients at the hospital entrance. Those who are suspected of having 2019-nCoV infection are sent to a designated department. Those with a skin condition who are not suspected of being infected are allowed to go to a dermatology triage center, where they are examined again. If the second examination raises suspicion, they are sent to the designated 2019-nCoV department. If no infection is suspected, or a patient from the 2019-nCoV department is cleared, they are allowed access to the dermatology clinic.

The team also suggested that skin lesions associated with dermatological conditions could lead to increased risk of 2019-nCoV infection. Contacted by email, Dr. Tao outlined a theoretical risk that the virus could lead to infection through contact with subcutaneous tissues, mucosal surfaces, or blood vessels. He did not respond to a request for evidence that such a route of transmission had occurred.

However, Adam Friedman, MD, professor of dermatology at George Washington University, Washington, said he doubted any such transmission would occur since the virus does not infect keratinocytes, and expressed concern that the suggestion could add to the stigma experienced by dermatological patients, whose noticeable rashes can sometimes lead to social avoidance. “I don’t want to add to that,” said Dr. Friedman in an interview.

A critical aspect of dermatology is the immunosuppressive agents often used in dermatology patients. Such drugs could make them more susceptible to infections, or to worse outcomes in the event of disease. Dr. Friedman recounted sending a letter to one patient on an immunosuppressive medication, suggesting that she work remotely. “I think that’s something we have to think about in at-risk individuals. I know there’s such a focus on the elderly, but there’s a large population of individuals on medications that lower their immune system who are going to be at risk for more severe infections,” said Dr. Friedman.

To reduce patient exposure, the commentary recommended that dermatologists perform online consultation for mild and nonemergency cases.

The authors also covered hospitalized patients with primary or secondary skin conditions. A dermatologist is on site at the dermatology triage station to conduct in-depth assessments if needed. If a patient has a fever that is believed to be caused by a dermatologic condition, the on-site dermatologist assists in the consult.

Because some patients may only become symptomatic after admission to a ward, the authors recommend hospitals have a COVID-19 trained contingency group on hand to prevent and control outbreaks within the institution. The team should be in communication with respiratory intensive care and radiology departments to exclude 2019-nCoV when cases develop in-hospital, and to ensure proper care infected patients who require it.

When a hospitalized 2019-nCoV-infected patient has a skin condition requiring treatment, the authors recommend that pictures be sent to the dermatologist for evaluation, along with teleconferences to further assess the patient. If necessary, the dermatologist should go to the patient’s bedside, with as much information as possible related in advance in order to minimize bedside exposure.

There was no funding source. Dr. Tao and Dr. Friedman have no relevant financial conflicts.

The novel coronavirus (2019-nCoV) is presenting a severe challenge to global health care, but its impact isn’t just felt in the emergency department. Specialists, including dermatologists, must also navigate the presence of the virus and its impact on patients and practices.

Courtesy CDC

A new report from dermatologists in China’s Wuhan province, where the 2019-nCoV outbreak began, outlines initial experiences and provides a blueprint for triaging potential cases before they reach the dermatology clinic. Despite its presence in the epicenter of the outbreak, the hospital has not detected any 2019-nCoV-infected patients in any of its departments.

The commentary appeared in the British Journal of Dermatology and was authored by a group led by Juan Tao of Huazhong University of Science and Technology (Br J Dermatol. 2020 Mar 5. doi: 10.1111/bjd.19011).

The hospital triages all patients at the hospital entrance. Those who are suspected of having 2019-nCoV infection are sent to a designated department. Those with a skin condition who are not suspected of being infected are allowed to go to a dermatology triage center, where they are examined again. If the second examination raises suspicion, they are sent to the designated 2019-nCoV department. If no infection is suspected, or a patient from the 2019-nCoV department is cleared, they are allowed access to the dermatology clinic.

The team also suggested that skin lesions associated with dermatological conditions could lead to increased risk of 2019-nCoV infection. Contacted by email, Dr. Tao outlined a theoretical risk that the virus could lead to infection through contact with subcutaneous tissues, mucosal surfaces, or blood vessels. He did not respond to a request for evidence that such a route of transmission had occurred.

However, Adam Friedman, MD, professor of dermatology at George Washington University, Washington, said he doubted any such transmission would occur since the virus does not infect keratinocytes, and expressed concern that the suggestion could add to the stigma experienced by dermatological patients, whose noticeable rashes can sometimes lead to social avoidance. “I don’t want to add to that,” said Dr. Friedman in an interview.

A critical aspect of dermatology is the immunosuppressive agents often used in dermatology patients. Such drugs could make them more susceptible to infections, or to worse outcomes in the event of disease. Dr. Friedman recounted sending a letter to one patient on an immunosuppressive medication, suggesting that she work remotely. “I think that’s something we have to think about in at-risk individuals. I know there’s such a focus on the elderly, but there’s a large population of individuals on medications that lower their immune system who are going to be at risk for more severe infections,” said Dr. Friedman.

To reduce patient exposure, the commentary recommended that dermatologists perform online consultation for mild and nonemergency cases.

The authors also covered hospitalized patients with primary or secondary skin conditions. A dermatologist is on site at the dermatology triage station to conduct in-depth assessments if needed. If a patient has a fever that is believed to be caused by a dermatologic condition, the on-site dermatologist assists in the consult.

Because some patients may only become symptomatic after admission to a ward, the authors recommend hospitals have a COVID-19 trained contingency group on hand to prevent and control outbreaks within the institution. The team should be in communication with respiratory intensive care and radiology departments to exclude 2019-nCoV when cases develop in-hospital, and to ensure proper care infected patients who require it.

When a hospitalized 2019-nCoV-infected patient has a skin condition requiring treatment, the authors recommend that pictures be sent to the dermatologist for evaluation, along with teleconferences to further assess the patient. If necessary, the dermatologist should go to the patient’s bedside, with as much information as possible related in advance in order to minimize bedside exposure.

There was no funding source. Dr. Tao and Dr. Friedman have no relevant financial conflicts.

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

Patients who did not survive hospitalization for COVID-19 in Wuhan were more likely to be older, have comorbidities, and elevated D-dimer, according to the first study to examine risk factors associated with death among adults hospitalized with COVID-19. “Older age, showing signs of sepsis on admission, underlying diseases like high blood pressure and diabetes, and the prolonged use of noninvasive ventilation were important factors in the deaths of these patients,” coauthor Zhibo Liu said in a news release. Abnormal blood clotting was part of the clinical picture too.

Fei Zhou, MD, from the Chinese Academy of Medical Sciences, and colleagues conducted a retrospective, observational, multicenter cohort study of 191 patients, 137 of whom were discharged and 54 of whom died in the hospital.

The study, published online today in The Lancet, included all adult inpatients with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital who had been discharged or died by January 31 of this year. Severely ill patients in the province were transferred to these hospitals until February 1.

The researchers compared demographic, clinical, treatment, and laboratory data from electronic medical records between survivors and those who succumbed to the disease. The analysis also tested serial samples for viral RNA. Overall, 91 (48%) of the 191 patients had comorbidity. Most common was hypertension (30%), followed by diabetes (19%) and coronary heart disease (8%).

The odds of dying in the hospital increased with age (odds ratio 1.10; 95% confidence interval, 1.03-1.17; per year increase in age), higher Sequential Organ Failure Assessment (SOFA) score (5.65, 2.61-12.23; P < .0001), and D-dimer level exceeding 1 mcg/L on admission. The SOFA was previously called the “sepsis-related organ failure assessment score” and assesses rate of organ failure in intensive care units. Elevated D-dimer indicates increased risk of abnormal blood clotting, such as deep vein thrombosis.

Nonsurvivors compared with survivors had higher frequencies of respiratory failure (98% vs 36%), sepsis (100%, vs 42%), and secondary infections (50% vs 1%).

The average age of survivors was 52 years compared to 69 for those who died. Liu cited weakening of the immune system and increased inflammation, which damages organs and also promotes viral replication, as explanations for the age effect.

From the time of initial symptoms, median time to discharge from the hospital was 22 days. Average time to death was 18.5 days.

Fever persisted for a median of 12 days among all patients, and cough persisted for a median 19 days; 45% of the survivors were still coughing on discharge. In survivors, shortness of breath improved after 13 days, but persisted until death in the others.

Viral shedding persisted for a median duration of 20 days in survivors, ranging from 8 to 37. The virus (SARS-CoV-2) was detectable in nonsurvivors until death. Antiviral treatment did not curtail viral shedding.

But the viral shedding data come with a caveat. “The extended viral shedding noted in our study has important implications for guiding decisions around isolation precautions and antiviral treatment in patients with confirmed COVID-19 infection. However, we need to be clear that viral shedding time should not be confused with other self-isolation guidance for people who may have been exposed to COVID-19 but do not have symptoms, as this guidance is based on the incubation time of the virus,” explained colead author Bin Cao.

“Older age, elevated D-dimer levels, and high SOFA score could help clinicians to identify at an early stage those patients with COVID-19 who have poor prognosis. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future,” the researchers conclude.

A limitation in interpreting the findings of the study is that hospitalized patients do not represent the entire infected population. The researchers caution that “the number of deaths does not reflect the true mortality of COVID-19.” They also note that they did not have enough genetic material to accurately assess duration of viral shedding.

This article first appeared on Medscape.com.

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

[email protected]

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

[email protected]

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

[email protected]

With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

With coronavirus disease (COVID-19) reaching epidemic proportions, many US children are growing increasingly anxious about what this means for their own health and safety and that of their friends and family.

The constantly changing numbers of people affected by the virus and the evolving situation mean daily life for many children is affected in some way, with school trips, sports tournaments, and family vacations being postponed or canceled.

All children may have a heightened level of worry, and some who are normally anxious might be obsessing more about handwashing or getting sick.

Experts say there are ways to manage this fear to help children feel safe and appropriately informed.

Clinicians and other adults should provide children with honest and accurate information geared to their age and developmental level, said David Fassler, MD, clinical professor of psychiatry, University of Vermont Larner College of Medicine, Burlington, and member of the Consumer Issues Committee of the American Academy of Child and Adolescent Psychiatry.

That said, it’s also acceptable to let children know that some questions can’t be answered, said Fassler.
 

Be truthful, calm

“This is partly because the information keeps changing as we learn more about how the virus spreads, how to best protect communities, and how to treat people who get sick,” he added.

Clinicians and parents should remind children “that there are a lot of adults who are working very hard to keep them safe,” said Eli R. Lebowitz, PhD, associate professor in the Child Study Center, Yale School of Medicine, New Haven, Connecticut, who directs a program for anxiety.

It’s important for adults to pay attention not only to what they say to children but also how they say it, said Lebowitz. He highlighted the importance of talking about the virus “in a calm and matter-of-fact way” rather than in an anxious way.

“If you look scared or tense or your voice is conveying that you’re really scared, the child is going to absorb that and feel anxious as well,” he noted.

This advice also applies when adults are discussing the issue among themselves. They should be aware that “children are listening” and are picking up any anxiety or panic adults are expressing.

Children are soaking up information about this virus from the Internet, the media, friends, teachers, and elsewhere. Lebowitz suggests asking children what they have already heard, which provides an opportunity to correct rumors and inaccurate information.

“A child might have a very inflated sense of what the actual risk is. For example, they may think that anyone who gets the virus dies,” he said.
 

Myth busting

Adults should let children know that not everything they hear from friends or on the Internet “is necessarily correct,” he added.

Some children who have experienced serious illness or losses may be particularly vulnerable to experiencing intense reactions to graphic news reports or images of illness or death and may need extra support, said Fassler.

Adults could use the “framework of knowledge” that children already have, said Lebowitz. He noted that all children are aware of sickness.

“They know people get sick, and they themselves have probably been sick, so you can tell them that this is a sickness like a bad flu,” he said.

Children should be encouraged to approach adults they trust, such as their pediatrician, a parent, or a teacher, with their questions, said Lebowitz. “Those are the people who are able to give them the most accurate information.”

Fassler noted that accurate, up-to-date information is available via fact sheets developed by the Centers for Disease Control and Prevention and the World Health Organization.

Although it’s helpful and appropriate to be reassuring, Fassler advises not to make unrealistic promises.

“It’s fine to tell kids that you’ll deal with whatever happens, even if it means altering travel plans or work schedules, but you can’t promise that no one in your state or community will get sick,” he said.
 

Maintain healthy habits

Physicians and other adults can tell children “in an age-appropriate way” how the virus is transmitted and what the symptoms are, but it’s important to emphasize that most people who are sick don’t have COVID-19, said Lebowitz.

“I would emphasize that the people who are the sickest are the elderly who are already sick, rather than healthy younger people,” he said.

Lebowitz recommends continuing to follow guidelines on staying healthy, including coughing into a sleeve instead of your hand and regular handwashing.

It’s also important at this time for children to maintain healthy habits – getting enough physical activity and sleep, eating well, and being outside – because this regime will go a long way toward reducing anxiety, said Lebowitz. Deep breathing and muscle-relaxing exercises can also help, he said.

Lebowitz also suggests maintaining a supportive attitude and showing “some acceptance and validation of what children are feeling, as well as some confidence that they can cope and tolerate feeling uncomfortable sometimes, that they can handle some anxiety.”

While accepting that the child could be anxious, it’s important not to encourage excessive avoidance or unhealthy coping strategies. Fassler and Lebowitz agree that children who are overly anxious or preoccupied with concerns about the coronavirus should be evaluated by a trained, qualified mental health professional.

Signs that a child may need additional help include ongoing sleep difficulties, intrusive thoughts or worries, obsessive-compulsive behaviors, or reluctance or refusal to go to school, said Fassler.

The good news is that most children are resilient, said Fassler. “They’ll adjust, adapt, and go on with their lives.”

This article first appeared on Medscape.com.

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

[email protected]

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

[email protected]

Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.

Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.

However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.

“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.

The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.

The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.

Symptoms developed within 11.5 days for 97.5% of patients in the study.

Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.

In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.

“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.

Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.

“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.

Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.

“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
 

SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.

Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.

Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.

However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.

“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.

The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.

The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.

Symptoms developed within 11.5 days for 97.5% of patients in the study.

Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.

In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.

“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.

Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.

“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.

Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.

“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
 

SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.

Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.

Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.

However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.

“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.

The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.

The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.

Symptoms developed within 11.5 days for 97.5% of patients in the study.

Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.

In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.

“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.

Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.

“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.

Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.

“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.

The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
 

SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

[email protected]

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

[email protected]

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.

LOS ANGELES – The edge that the direct-acting oral anticoagulant apixaban (Eliquis) has over warfarin for safely preventing ischemic events in patients with atrial fibrillation and either a recent acute coronary syndrome event or a recent percutaneous coronary intervention held up even in patients with a history of stroke, transient ischemic attack, or thromboembolic event, according to a prespecified secondary analysis of data collected in the AUGUSTUS trial.

Mitchel L. Zoler/MDedge News

The treatment advantages of apixaban, compared with warfarin, seen in the overall AUGUSTUS results, first reported in March 2019, “were consistent” with the benefits seen in the subgroup of enrolled patients with a prior stroke, transient ischemic attack (TIA), or thromboembolic (TE) event, M. Cecilia Bahit, MD, said at the International Stroke Conference sponsored by the American Heart Association.

All patients in AUGUSTUS received a P2Y12 inhibitor antiplatelet drug, which was clopidogrel for more than 90% of patients. The two-by-two factorial design of AUGUSTUS also assessed the safety and efficacy of either adding or withholding aspirin from the two-drug regimen that all patients in the study received with a P2Y12 inhibitor plus an anticoagulant (apixaban or warfarin). The most notable finding of the aspirin versus placebo analysis was that patients without a prior stroke, TIA, or TE event had a “more profound” increase in their rate of major or clinically relevant minor bleeds when also treated with aspirin, compared with patients who received aspirin and had a history of stroke, TIA, or TE event, reported Dr. Bahit, a chief of cardiology and director of clinical research at the INECO Foundation in Rosario, Argentina.

In general, the findings of the secondary analysis that took into account stroke, TIA, or TE history “confirmed” the main AUGUSTUS findings, Dr. Bahit said; an antithrombotic regimen of apixaban plus clopidogrel (or other P2Y12 inhibitor) without aspirin was superior for both efficacy and safety, compared with the alternative regimens that either substituted warfarin for apixaban or that added aspirin.

AUGUSTUS enrolled 4,614 atrial fibrillation (AFib) patients who either had a recent acute coronary syndrome (ACS) event or had recently undergone percutaneous coronary intervention (PCI) at any of 492 sites in 33 countries during 2015-2018. The study’s primary endpoint was the incidence of major or clinically relevant minor bleeds after 6 months, which was significantly lower in the subgroups that received apixaban instead of warfarin and in patients who received placebo instead of aspirin. The secondary endpoint of death or hospitalization after 6 months was also significantly lower in the apixaban-treated patients, compared with those on warfarin, while the aspirin and placebo subgroups showed no difference in the incidence of these events (N Engl J Med. 2019 Apr 18;380[16]:1509-24).

The results reported by Dr. Bahit also highlighted both the high risk faced by patients with AFib who also have had an ACS event or PCI, as well as a prior stroke, TIA, or TE event, noted Larry B. Goldstein, MD, professor and chairman of neurology at the University of Kentucky, Lexington. “It’s difficult, because these patients had an ACS event or PCI, and you don’t want a coronary too close up, but do these patients really need a P2Y12 inhibitor plus an anticoagulant? Could these patients do as well on apixaban only? I would have liked to see that treatment arm in the study,” Dr. Goldstein commented in an interview.

“These are challenging patients because they often require anticoagulation for the AFib as well as antiplatelet agents” for the recent PCI or ACS event, commented Mitchell S.V. Elkind, MD, professor of neurology at Columbia University, New York. “The question has always been: How many blood thinners should these patients be on? Potentially they could be on three different agents [an anticoagulant and two antiplatelet drugs], and we know that all of those drugs together pretty dramatically increase the risk of bleeding. About 15% of the patients in the overall AUGUSTUS trial had either cerebrovascular disease or systemic thromboembolism, so this was a small subgroup of the overall trial, but the overall trial was large so it’s a significant number of patients who met this criteria. The results confirmed that even in a group of patients who may be considered at high risk because they have a prior history of cerebrovascular disease use of apixaban instead of warfarin seemed safer, and that those patients did not need to be on aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial, so one could argue that they should be on an agent like apixaban as well as an antiplatelet agent like clopidogrel without addition of aspirin,” he said in a recorded statement.

In addition to implications for using prescription drugs like apixaban and clopidogrel, the findings also send a message about the need for very aggressive implementation of lifestyle measures that can reduce cardiovascular disease risk in these patients, added Dr. Goldstein. The AUGUSTUS outcome analyses that subdivided the study population into those with a prior stroke, TIA, or TE event – 633 patients or about 14% of the 4,581 patients eligible for this analysis – and those who did not have this history showed the extremely high, incrementally elevated risk faced by patients with these prior events.

A history of stroke, TIA, or TE event linked with a jump in the 90-day rate of major or clinically relevant minor bleeds from 13% without this history to 17%, which is a 31% relative increase; it boosted the 90-day rate of death or hospitalization from 25% to 31%, a 24% relative increase; and it jacked up the rate of death or ischemic events from 6% to 9%, a 50% relative increase, Dr. Bahit reported.

These substantial increases “suggest we need to be very aggressive” in managing these high-risk patients who combine a background of AFib, a prior stroke, TIA, or TE events, and a recent ACS event or PCI, Dr. Goldstein observed. In these patients, he suggested that clinicians make sure to address smoking cessation, obesity, exercise, diet, and statin use, and get each of these to an optimal level to further cut risk. If all five of these basic interventions were successfully administered to a patient they could collectively cut the patient’s event risk by about 80%, he added.

AUGUSTUS was funded by Bristol-Myers Squibb and Pfizer, the companies that jointly market apixaban. Dr. Bahit has received honoraria from Pfizer, and from CSL Behring and Merck. Dr. Elkind and Dr. Goldstein had no relevant disclosures.

[email protected]

SOURCE: Bahit MC et al. ISC 2020, Abstract LB22.