Covid ICYMI

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.

“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.

Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.

The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.

Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.

“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”

The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”

“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”

In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”

According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”

“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.

“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.

“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”

The document also recommends shorter courses of RT when radiation is deemed appropriate.

“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”

“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.

Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”

Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.

Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”

“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.

Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.

“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.

“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
 

This article first appeared on Medscape.com.

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Influenza activity measures dropped during the week ending March 28, but the percentage of deaths attributed to pneumonia and influenza (P&I) has risen into epidemic territory, according to the Centers for Disease Control and Prevention.

This influenza news, however, needs to be viewed through a COVID-19 lens.

The P&I mortality data are reported together and are always a week behind the other measures, in this case covering the week ending March 21, but they show influenza deaths dropping to 0.8% as the overall P&I rate rose from 7.4% to 8.2%, a pneumonia-fueled increase that was “likely associated with COVID-19 rather than influenza,” the CDC’s influenza division noted.

The two main activity measures, at least, are on the same page for the first time since the end of February.

The rate of outpatient visits for influenza-like illness (ILI) had been dropping up to that point but then rose for an unprecedented third time this season, a change probably brought about by COVID-related health care–seeking behavior, the influenza division reported in its weekly FluView report.

This corresponding third drop in ILI activity brought the rate down to 5.4% this week from 6.2% the previous week, the CDC reported. The two previous high points occurred during the weeks ending Dec. 28 (7.0%) and Feb. 8 (6.7%)

The COVID-related changes, such as increased use of telemedicine and social distancing, “impact data from [the Outpatient Influenza-Like Illness Surveillance Network] in ways that are difficult to differentiate from changes in illness levels and should be interpreted with caution,” the CDC investigators noted.

The other activity measure, positive tests of respiratory specimens for influenza at clinical laboratories, continued the decline that started in mid-February by falling from 7.3% to 2.1%, its lowest rate since October, CDC data show.

Overall flu-related deaths may be down, but mortality in children continued at a near-record level. Seven such deaths were reported this past week, which brings the total for the 2019-2020 season to 162. “This number is higher than recorded at the same time in every season since reporting began in 2004-05, except for the 2009 pandemic,” the CDC noted.

rfranki@mdedge.com

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Recent research has shown that severe cases of COVID-19 show an excessive immune response and a strong cytokine storm, which may include high levels of granulocyte-macrophage colony-stimulating factor (GSF) and interleukin-6 (IL-6). Following up on that research, investigators from China reported the first case of COVID-19 in a patient with multiple myeloma (MM) who was successfully treated with the humanized anti–IL-6 receptor antibody tocilizumab (an off-label use in the United States). The exceptional case report was published online in Blood Advances, an American Society of Hematology journal.

A 60-year-old man working in Wuhan, China, developed chest tightness without fever and cough on Feb. 1, 2020, and was admitted immediately after computed tomography (CT) imaging of his chest showed multiple ground-glass opacities and pneumatocele located in both subpleural spaces. He received 400 mg of moxifloxacin IV daily for 3 days while swab specimens were collected and tested by real-time reverse transcriptase–polymerase chain reaction. A positive result for SARS-CoV-2 infection was received 3 days later. The patient was subsequently given 200-mg umifenovir (Arbidol) tablets orally, three times daily, for antiviral treatment.

The patient had a history of symptomatic MM, which was diagnosed in 2015. The patient received two cycles of induction chemotherapy consisting of bortezomib, thalidomide, and dexamethasone, and his symptoms completely disappeared. After that, he received thalidomide for maintenance.

Chest CT imaging on hospital day 8 showed that the bilateral, multiple ground-glass opacities from the first scan remained, and laboratory investigations revealed a high level of serum IL-6. On hospital day 9, the patient was given a single, one-time dose of 8 mg/kg tocilizumab, administered by IV. On hospital day 12, his chest tightness disappeared. “After tocilizumab administration, the IL-6 level decreased gradually over the following 10 days (from 121.59 to 20.81 pg/mL), then increased rapidly to the peak (317.38 pg/mL), and then decreased to a low level (117.10 pg/mL). The transient rebounding of the IL-6 level to the peak does not mean COVID-19 relapse: Instead, this might be attributed to the recovery of the normal T cells,” the authors wrote.

On hospital day 19, the patient’s chest CT scan showed that the range of ground-glass opacities had obviously decreased, and he was declared cured and discharged from the hospital. The patient had no symptoms of MM, and related laboratory findings were all in normal ranges, according to the researchers.

“This case is the first to prove that tocilizumab is effective in the treatment of COVID-19 in MM with obvious clinical recovery; however, randomized controlled trials are needed to determine the safety and efficacy of tocilizumab,” the researchers concluded.

The authors declared that they had no conflicts of interest.

mlesney@mdedge.com

SOURCE: Zhang X et al. Blood Adv. 2020;4(7):1307-10.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

Curative treatments for metastatic prostate, renal, and urothelial cancer – and germ cell tumors – should continue as usual amid the COVID-19 pandemic, but “the risk/benefit ratio of a number of palliative and (neo)adjuvant treatments has to be reconsidered,” according to an editorial set to be published in European Urology.

“Regimens with a clear survival advantage should be prioritized, with curative treatments remaining mandatory,” wrote Silke Gillessen Sommer, MD, of Istituto Oncologico della Svizzera Italiana in Bellizona, Switzerland, and Thomas Powles, MD, of Barts Cancer Institute in London.

However, it may be appropriate to stop or delay therapies with modest or unproven survival benefits. “Delaying the start of therapy ... is an appropriate measure for many of the therapies in urology cancer,” they wrote.
 

Timely recommendations for oncologists

The COVID-19 pandemic is limiting resources for cancer, noted Zachery Reichert, MD, PhD, a urological oncologist and assistant professor at the University of Michigan, Ann Arbor, who was asked for his thoughts about the editorial.

Oncologists and oncology nurses are being shifted to care for COVID-19 patients, space once devoted to cancer care is being repurposed for the pandemic, and personal protective equipment needed to prepare chemotherapies is in short supply.

Meanwhile, cancer patients are at increased risk of dying from the virus (Lancet Oncol. 2020;21:335-7), so there’s a need to minimize their contact with the health care system to protect them from nosocomial infection, and a need to keep their immune system as strong as possible to fight it off.

To help cancer patients fight off infection and keep them out of the hospital, the editorialists recommended growth factors and prophylactic antibiotics after chemotherapy, palliative therapies at doses that avoid febrile neutropenia, discontinuing steroids or at least reducing their doses, and avoiding bisphosphonates if they involve potential COVID-19 exposure in medical facilities.

The advice in the editorial mirrors many of the discussions going on right now at the University of Michigan, Dr. Reichert said, and perhaps other oncology services across the United States.

It will come down to how severe the pandemic becomes locally, but he said it seems likely “a lot of us are going to be wearing a different hat for a while.”

Patients who have symptoms from a growing tumor will likely take precedence at the university, but treatment might be postponed until after COVID-19 peaks if tumors don’t affect quality of life. Also, bladder cancer surgery will probably remain urgent “because the longer you wait, the worse the outcomes,” but perhaps not prostate and kidney cancer surgery, where delay is safer, Dr. Reichert said.
 

Prostate/renal cancers and germ cell tumors

The editorialists noted that oral androgen receptor therapy should be preferred over chemotherapy for prostate cancer. Dr. Reichert explained that’s because androgen blockade is effective, requires less contact with health care providers, and doesn’t suppress the immune system or tie up hospital resources as much as chemotherapy. “In the world we are in right now, oral pills are a better choice,” he said.

The editorialists recommended against both nephrectomy for metastatic renal cancer and adjuvant therapy after orchidectomy for stage 1 germ cell tumors for similar reasons, and also because there’s minimal evidence of benefit.

Dr. Powles and Dr. Gillessen Sommer suggested considering a break from immune checkpoint inhibitors (ICIs) and oral vascular endothelial growth factors (VEGFs) for renal cancer patients who have been on them a year or two. It’s something that would be considered even under normal circumstances, Dr. Reichert explained, but it’s more urgent now to keep people out of the hospital. VEGFs should also be prioritized over ICIs; they have similar efficacy in renal cancer, but VEGFs are a pill.

They also called for oncologists to favor conventional-dose treatments for germ cell tumors over high-dose treatments, meaning bone marrow transplants or high-intensity chemotherapy. Amid a pandemic, the preference is for options “that don’t require a hospital bed,” Dr. Reichert said.
 

Urothelial cancer

Dr. Powles and Dr. Gillessen Sommer suggested not starting or continuing second-line chemotherapies in urothelial cancer patients refractory to first-line platinum-based therapies. The chance they will respond to second-line options is low, perhaps around 10%. That might have been enough before the pandemic, but it’s less justified amid resource shortages and the risk of COVID-19 in the infusion suite, Dr. Reichert explained.

Along the same lines, they also suggested reconsidering perioperative chemotherapy for urothelial cancer, and, if it’s still a go, recommended against going past three cycles, as the benefits in both scenarios are likely marginal. However, if COVID-19 cancels surgeries, neoadjuvant therapy might be the right – and only – call, according to the editorialists.

They recommended prioritizing ICIs over chemotherapy in patients with metastatic urothelial cancer who are positive for programmed death-ligand 1 (PD-L1). PD-L1–positive patients have a good chance of responding, and ICIs don’t suppress the immune system.

“Chemotherapy still has a slightly higher percent response, but right now, this is a better choice for” PD-L1-positive patients, Dr. Reichert said.

Dr. Gillessen Sommer and Dr. Powles disclosed ties to Bristol-Myers Squibb, Roche, and numerous other companies. Dr. Reichert has no relevant disclosures.

aotto@mdedge.com

SOURCE: Gillessen Sommer S, Powles T. “Advice regarding systemic therapy in patients with urological cancers during the COVID-19 pandemic.” Eur Urol. https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/eururo/EURUROL-D-20-00382-1585928967060.pdf.

The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic.

“It is reasonable to believe that your product may be effective in diagnosing COVID-19,” and “there is no adequate, approved, and available alternative,” the agency said in a letter to Cellex.

A drop of serum, plasma, or whole blood is placed into a well on a small cartridge, and the results are read 15-20 minutes later; lines indicate the presence of IgM, IgG, or both antibodies against the SARS-CoV-2 virus.

Of 128 samples confirmed positive by reverse transcription polymerase chain reaction in premarket testing, 120 tested positive by IgG, IgM, or both. Of 250 confirmed negative, 239 were negative by the rapid test.

The numbers translated to a positive percent agreement with RT-PCR of 93.8% (95% CI: 88.06-97.26%) and a negative percent agreement of 96.4% (95% CI: 92.26-97.78%), according to labeling.

“Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection,” the labeling states.

Negative results do not rule out infection; antibodies might not have had enough time to form or the virus could have had a minor amino acid mutation in the epitope recognized by the antibodies screened for in the test. False positives can occur due to cross-reactivity with antibodies from previous infections, such as from other coronaviruses.

Labeling suggests that people who test negative should be checked again in a few days, and positive results should be confirmed by other methods. Also, the intensity of the test lines do not necessarily correlate with SARS-CoV-2 antibody titers.

As part of its authorization, the FDA waived good manufacturing practice requirements, but stipulated that advertising must state that the test has not been formally approved by the agency.

Testing is limited to Clinical Laboratory Improvement Amendments-certified labs. Positive results are required to be reported to public health authorities. The test can be ordered through Cellex distributors or directly from the company.

IgM antibodies are generally detectable several days after the initial infection, while IgG antibodies take longer. It’s not known how long COVID-19 antibodies persist after the infection has cleared, the agency said.

aotto@mdedge.com

The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic.

“It is reasonable to believe that your product may be effective in diagnosing COVID-19,” and “there is no adequate, approved, and available alternative,” the agency said in a letter to Cellex.

A drop of serum, plasma, or whole blood is placed into a well on a small cartridge, and the results are read 15-20 minutes later; lines indicate the presence of IgM, IgG, or both antibodies against the SARS-CoV-2 virus.

Of 128 samples confirmed positive by reverse transcription polymerase chain reaction in premarket testing, 120 tested positive by IgG, IgM, or both. Of 250 confirmed negative, 239 were negative by the rapid test.

The numbers translated to a positive percent agreement with RT-PCR of 93.8% (95% CI: 88.06-97.26%) and a negative percent agreement of 96.4% (95% CI: 92.26-97.78%), according to labeling.

“Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection,” the labeling states.

Negative results do not rule out infection; antibodies might not have had enough time to form or the virus could have had a minor amino acid mutation in the epitope recognized by the antibodies screened for in the test. False positives can occur due to cross-reactivity with antibodies from previous infections, such as from other coronaviruses.

Labeling suggests that people who test negative should be checked again in a few days, and positive results should be confirmed by other methods. Also, the intensity of the test lines do not necessarily correlate with SARS-CoV-2 antibody titers.

As part of its authorization, the FDA waived good manufacturing practice requirements, but stipulated that advertising must state that the test has not been formally approved by the agency.

Testing is limited to Clinical Laboratory Improvement Amendments-certified labs. Positive results are required to be reported to public health authorities. The test can be ordered through Cellex distributors or directly from the company.

IgM antibodies are generally detectable several days after the initial infection, while IgG antibodies take longer. It’s not known how long COVID-19 antibodies persist after the infection has cleared, the agency said.

aotto@mdedge.com

The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a rapid antibody test for COVID-19, the first antibody test released amidst the pandemic.

“It is reasonable to believe that your product may be effective in diagnosing COVID-19,” and “there is no adequate, approved, and available alternative,” the agency said in a letter to Cellex.

A drop of serum, plasma, or whole blood is placed into a well on a small cartridge, and the results are read 15-20 minutes later; lines indicate the presence of IgM, IgG, or both antibodies against the SARS-CoV-2 virus.

Of 128 samples confirmed positive by reverse transcription polymerase chain reaction in premarket testing, 120 tested positive by IgG, IgM, or both. Of 250 confirmed negative, 239 were negative by the rapid test.

The numbers translated to a positive percent agreement with RT-PCR of 93.8% (95% CI: 88.06-97.26%) and a negative percent agreement of 96.4% (95% CI: 92.26-97.78%), according to labeling.

“Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection,” the labeling states.

Negative results do not rule out infection; antibodies might not have had enough time to form or the virus could have had a minor amino acid mutation in the epitope recognized by the antibodies screened for in the test. False positives can occur due to cross-reactivity with antibodies from previous infections, such as from other coronaviruses.

Labeling suggests that people who test negative should be checked again in a few days, and positive results should be confirmed by other methods. Also, the intensity of the test lines do not necessarily correlate with SARS-CoV-2 antibody titers.

As part of its authorization, the FDA waived good manufacturing practice requirements, but stipulated that advertising must state that the test has not been formally approved by the agency.

Testing is limited to Clinical Laboratory Improvement Amendments-certified labs. Positive results are required to be reported to public health authorities. The test can be ordered through Cellex distributors or directly from the company.

IgM antibodies are generally detectable several days after the initial infection, while IgG antibodies take longer. It’s not known how long COVID-19 antibodies persist after the infection has cleared, the agency said.

aotto@mdedge.com

As the COVID-19 pandemic sweeps across the United States, it is increasingly affecting those who are not infected. Social bonds are being broken, businesses are closing, jobs are being lost, and the stress is mounting.

In a poll conducted March 25-30, 45% of Americans said that stress resulting from the pandemic is having a negative impact on their mental health, compared with 32% expressing that view just 2 weeks earlier, the Kaiser Family Foundation reported April 2.

In the later survey, the effect looked like this: 19% of all respondents said that the pandemic has had a major negative impact and 26% said it has been minor so far. Women were more likely than men (24% vs. 15%) to report a major impact, as were blacks and Hispanic adults (both at 24%) compared with whites (17%), the KFF investigators said.

More Hispanic (44%) and black (42%) respondents also said that they had already lost their job, lost income, or had their hours reduced without pay as a result of the pandemic, compared with whites (36%). Among all respondents, 26% had lost income from a job or business and 28% had lost their job, been laid off, or had their hours reduced without pay, according to KFF.

A majority of respondents (57%) reported “being worried they will put themselves at risk of exposure to coronavirus because they can’t afford to stay home and miss work,” the researchers said. That figure is up from 35% in the earlier survey.

Anxiety about work-related exposure was even higher among hourly workers or those who get paid by the job (61%) and among employed adults who earn less than $40,000 annually (72%), they reported.

Overall, 72% of respondents said that their lives have been disrupted “a lot” or “some” by the coronavirus outbreak, and that is a jump of 32 percentage points over the previous poll, the investigators noted.

The disruption is expected to continue, it seems, as 74% believe that the worst is yet to come “in spite of the health, social and economic upheaval that Americans are already experiencing,” they wrote.

rfranki@mdedge.com

As the COVID-19 pandemic sweeps across the United States, it is increasingly affecting those who are not infected. Social bonds are being broken, businesses are closing, jobs are being lost, and the stress is mounting.

In a poll conducted March 25-30, 45% of Americans said that stress resulting from the pandemic is having a negative impact on their mental health, compared with 32% expressing that view just 2 weeks earlier, the Kaiser Family Foundation reported April 2.

In the later survey, the effect looked like this: 19% of all respondents said that the pandemic has had a major negative impact and 26% said it has been minor so far. Women were more likely than men (24% vs. 15%) to report a major impact, as were blacks and Hispanic adults (both at 24%) compared with whites (17%), the KFF investigators said.

More Hispanic (44%) and black (42%) respondents also said that they had already lost their job, lost income, or had their hours reduced without pay as a result of the pandemic, compared with whites (36%). Among all respondents, 26% had lost income from a job or business and 28% had lost their job, been laid off, or had their hours reduced without pay, according to KFF.

A majority of respondents (57%) reported “being worried they will put themselves at risk of exposure to coronavirus because they can’t afford to stay home and miss work,” the researchers said. That figure is up from 35% in the earlier survey.

Anxiety about work-related exposure was even higher among hourly workers or those who get paid by the job (61%) and among employed adults who earn less than $40,000 annually (72%), they reported.

Overall, 72% of respondents said that their lives have been disrupted “a lot” or “some” by the coronavirus outbreak, and that is a jump of 32 percentage points over the previous poll, the investigators noted.

The disruption is expected to continue, it seems, as 74% believe that the worst is yet to come “in spite of the health, social and economic upheaval that Americans are already experiencing,” they wrote.

rfranki@mdedge.com

As the COVID-19 pandemic sweeps across the United States, it is increasingly affecting those who are not infected. Social bonds are being broken, businesses are closing, jobs are being lost, and the stress is mounting.

In a poll conducted March 25-30, 45% of Americans said that stress resulting from the pandemic is having a negative impact on their mental health, compared with 32% expressing that view just 2 weeks earlier, the Kaiser Family Foundation reported April 2.

In the later survey, the effect looked like this: 19% of all respondents said that the pandemic has had a major negative impact and 26% said it has been minor so far. Women were more likely than men (24% vs. 15%) to report a major impact, as were blacks and Hispanic adults (both at 24%) compared with whites (17%), the KFF investigators said.

More Hispanic (44%) and black (42%) respondents also said that they had already lost their job, lost income, or had their hours reduced without pay as a result of the pandemic, compared with whites (36%). Among all respondents, 26% had lost income from a job or business and 28% had lost their job, been laid off, or had their hours reduced without pay, according to KFF.

A majority of respondents (57%) reported “being worried they will put themselves at risk of exposure to coronavirus because they can’t afford to stay home and miss work,” the researchers said. That figure is up from 35% in the earlier survey.

Anxiety about work-related exposure was even higher among hourly workers or those who get paid by the job (61%) and among employed adults who earn less than $40,000 annually (72%), they reported.

Overall, 72% of respondents said that their lives have been disrupted “a lot” or “some” by the coronavirus outbreak, and that is a jump of 32 percentage points over the previous poll, the investigators noted.

The disruption is expected to continue, it seems, as 74% believe that the worst is yet to come “in spite of the health, social and economic upheaval that Americans are already experiencing,” they wrote.

rfranki@mdedge.com

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

The growing threat of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), now commonly known as coronavirus disease 2019 (COVID-19), has forced Americans to stay home due to quarantine, especially older individuals and those who are immunocompromised or have an underlying health problem such as pulmonary or cardiac disease. The federal government’s estimated $2 trillion CARES Act (Coronavirus Aid, Relief, and Economic Security Act)¹ will provide a much-needed boost to health care and the economy; prior recent legislation approved an $8.6 billion emergency relief bill,² HR 6074 (Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020), which expands Medicare coverage of telehealth to patients in their home rather than having them travel to a designated site, covers both established and new patients, allows physicians to waive or reduce co-payments and cost-sharing requirements, and reimburses the same as an in-person visit.

Federal emergency legislation temporarily relaxed the Health Insurance Portability and Accountability Act (HIPAA),^3,4 allowing physicians to use Facetime and Skype for Medicare patients. In addition, Medicare will reimburse telehealth services for out-of-state-providers; however, cross-state licensure is governed by the patient’s home state.⁵ As of March 25, 2020, emergency legislation to temporarily allow out-of-state physicians to provide care, whether or not it relates to COVID-19, was enacted in 13 states: California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Indiana, Iowa, Maryland, Minnesota, New York, North Carolina, and North Dakota.⁶ Ongoing legislation is rapidly changing; for daily updates on licensing laws, refer to the Federation of State Medical Boards website. Check your own institutional policies and malpractice provider prior to offering telehealth, as local laws and regulations may vary. Herein, we offer suggestions for using teledermatology.

Reimbursement

Prior to the COVID-19 pandemic, 16 states—Arkansas, Colorado, Delaware, Hawaii, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, Tennessee, Utah, and Virginia—had true payment parity laws,⁷ which reimbursed telehealth as a regular office visit using modifier -95. Several states have enacted emergency telehealth expansion laws to discourage COVID-19 spread⁸; some states such as New Jersey now prohibit co-payments or out-of-pocket deductibles from all in-network insurance plans (commercial Medicare and Medicaid).^9,10 Updated legislation about COVID-19 and telemedicine can be found on the Center for Connected Health Policy website. An interactive map of laws and reimbursement policies also is available on the websites of the American Telehealth Association and the American Academy of Dermatology. The ability to charge a patient directly for telehealth services depends on the insurance provider agreement. If telehealth is a covered service, you cannot charge these patients out-of-pocket.

Teledermatology Options

For many conditions, the effectiveness and quality of teledermatology is comparable to a conventional face-to-face visit.¹¹ There are 3 types of telehealth visits:

• Store and forward: The clinician reviews images or videos and responds asynchronously,¹² similar to an email chain.
• Live interactive: The clinician uses 2-way video synchronously.¹² In states with parity laws, this method is reimbursed equally to an in-person visit.
• Remote patient monitoring: Health-related data are collected and transmitted to a remote clinician, similar to remote intensive care unit management.¹² Dermatologists are unlikely to utilize this modality.

The Virtual Visit

Follow these guidelines for practicing teledermatology: (1) ensure that the image or video is clear and that there is proper lighting, a monochromatic background, and a clear view of the anatomy necessary to evaluate; (2) dress in appropriate attire as if you were in clinic, such as scrubs, a white coat, or other professional attire; (3) begin the telehealth encounter by obtaining informed consent,¹³ according to state¹⁴ or Medicare guidelines; (4) document the location of the patient and provider; (5) for live virtual visits, document similarly to an in-person visit⁵; (6) for all other virtual care, document minutes spent on each task; and (7) select only 1 billing code per visit.

In some states, regulations for commercial and/or Medicaid plans require that other modifiers be added to billing codes, which vary plan-by-plan:

• Modifier GQ: For asynchronous care (store and forward).
• Modifier GT: For synchronous live telehealth visits.
• Modifier -95: In states where there are equal parity laws or if you are billing a commercial insurance payer (may vary by plan).

Medicare does not require any additional modifiers.¹⁵ If the plan reimburses telemedicine equally to a face-to-face visit, use regular office visit codes. The eTable¹⁶ lists billing codes and Medicare reimbursement rates.

Secure Software

Several electronic medical record systems already include secure patient communication. Other HIPAA-compliant communication options with a variety of features are available to clinicians:

• Klara allows for HIPAA-secure texting, group messaging, photograph uploads, and telephone calls.
• Doximity offers free calling and faxes.
• G Suite for health care offers HIPAA-compliant texting, emailing, and video calls through Google Voice and Google Hangouts Meet.
• Secure video chat is available on Zoom for Healthcare, VSee, Doxy.me, and other platforms.
• Multiservice platforms such as DermEngine include billing, payments, teledermatology, and teledermoscopy and allow for interprofessional consultation.

The Bottom Line

Telehealth readiness is playing a key role in containing the spread of COVID-19. In-person dermatology visits are now being limited to urgent conditions only, as per institutional guidelines.⁴



Acknowledgment
We thank Garfunkel Wild, P.C. (Great Neck, New York), for their expertise and assistance.

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.

“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.

“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.

“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.

Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.

The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.

“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.

Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”

The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.

Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.

Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missouri, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”

Fory, Griffith, and Raji have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.






 

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

As the COVID-19 pandemic spreads over the country, nearly half (48%) of US healthcare facilities — of various types and sizes — are already or almost out of respirators for treating patients, according to the results of a national online survey of infection prevention professionals.

Conducted during March 23-25 by the Association for Professionals in Infection Control and Epidemiology (APIC), the survey asked APIC’s 11,922 US-based infection preventionist members to rank their facilities’ supply of personal protective equipment (PPE) and key items, such as hand sanitizer and cleaning products, on a 5-point scale from having “plenty” to “none.”

Overall, 1,140 (9.6%) infection preventionists responded. Almost 70% of respondents represented a healthcare system rather than a single facility, and facilities ranged from hospitals (42.7%) to ambulatory care (17.4%) and dialysis (2.7%). The centers, from all 50 states and Washington, D.C., ranged in size from those with 1 to 50 beds to those with more than 300 beds.

Of the respondents, 233 (20.4%) reported their facilities have no protective respirators and 317 (27.8%) said they were almost out of the devices, which are needed to protect healthcare workers managing patients with COVID-19 and different infectious diseases.

The survey was posted Friday on the APIC website.

Other findings from the survey include:

• Nearly half of respondents (49.2%) said their centers lack sufficient enough face shields, with 36.5% reporting being almost out and 12.6% reporting being completely out.
• Approximately one third (31.7%) of respondents reported being completely or nearly out of face masks.
• Even simple hand sanitizer is in short supply at more than 1 in 4 facilities surveyed; 25.6% of respondents said they are almost out and 2.6% are completely out.
• Nearly 30% of respondents reported accessing supplemental PPE through state or local resources, while 24.6% said they accepted private donations of supplies.
• Fewer than one-third (31.5%) said they had sufficient gowns.
• About 28% said they were almost out of protective respirators, while 20.5% said they have none.
• Only 12.3% said they have received supplies from federal resources, including the Strategic National Stockpile, which is controlled by the Department of Health and Human Services.
• 17.2% of respondents reported resorting to DIY measures such as sewing their own masks.

In terms of staffing resources, 67% of respondents said their center has only one (or fewer) full-time–equivalent infection preventionist on staff to develop protocols for managing COVID-19. That is not surprising given the general underresourcing of infection control programs, the survey compilers said.

“Hospitals and health facilities with fewer than one full-time person on staff to direct infection prevention activities may have been disadvantaged even before the COVID-19 pandemic,” said APIC president Connie Steed, MSN, RN, in a related news release.

On a more positive note, about two thirds of facilities said they have sufficient supplies of gloves (63.4%) and hand washing soap (67.1%).

“I am concerned that many facilities will not be able to protect healthcare workers and patients from not only COVID-19, but also MRSA, C diff., and other antibiotic-resistant infections,” Steed said.

At some centers, however, the situation is not so grim — yet. The large Harris Health System in Houston has enough PPE on hand to support all infection prevention protocols in place, according to Bryan McLeod, director of corporate communications. “The PPE inventory varies from a few weeks to well over a month depending on the specific item,” McLeod told Medscape Medical News. “But everything is dependent on the utilization rate, which can vary with patient volume. Our concern is long-term resupply while demand is peaking around the world, and we continue to pursue all avenues to secure resupply.”

Above all, Steed emphasizes healthcare workers’ need for clarity. “They need to know when exactly they can expect desperately needed supplies to arrive so they don’t have to turn to unproven crisis methods for PPE,” she said. “There have been grim reports from health officials about the supply shortage for weeks and we’re not getting any answers. This is unacceptable.”

APIC is urging the federal government for immediate activation of the Cold War–era Defense Production Act and any other available means to quickly manufacture vital supplies to protect healthcare workers treating the escalating numbers of COVID-19 patients.

In the meantime, frontline healthcare workers are scouring the Internet for suppliers and begging online for donations of masks.

APIC notes that the COVID-19 pandemic is compounded by this year’s particularly severe influenza season, which had already led overcrowded healthcare facilities.  
 

This article first appeared on Medscape.com.

Patients taking isotretinoin can use telemedicine to meet with their prescribing physicians instead of in-person visits, and female patients can use at-home pregnancy tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.

Obencem/Thinkstock

The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.

The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.

Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”

Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.

“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.

The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.

Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.

Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.

“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”

Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.

Patients taking isotretinoin can use telemedicine to meet with their prescribing physicians instead of in-person visits, and female patients can use at-home pregnancy tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.

Obencem/Thinkstock

The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.

The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.

Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”

Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.

“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.

The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.

Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.

Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.

“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”

Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.

Patients taking isotretinoin can use telemedicine to meet with their prescribing physicians instead of in-person visits, and female patients can use at-home pregnancy tests to comply with the requirements of the iPLEDGE program during the COVID-19 pandemic, according to an update program posted on the iPLEDGE website.

Obencem/Thinkstock

The program’s other requirements – the prescription window and two forms of birth control – remain unchanged.

The change follows recent guidance from the Department of Health & Human Services and the Food and Drug Administration regarding accommodations for medical care and drugs subject to Risk Evaluation and Mitigation Strategies (REMS) in the midst of a public health emergency that requires most people to remain in their homes except for essential services.

Allowing females to take at-home pregnancy tests and communicate the results to physician according to their preference is “a game changer for the middle of a pandemic, obviously,” Neil Goldberg, MD, a dermatologist in Westchester County, New York, said in an interview. “These are patients who don’t need to spend time outside just to get pregnancy tests done. It makes it a lot easier.”

Dr. Goldberg is frustrated, however, that the accommodations have not been more widely publicized; he discovered the change incidentally when speaking to an iPLEDGE program representative to request a waiver for a patient who had taken her pregnancy test too early. The program had denied a similar request for a 15-year-old patient of his the previous week, despite the patient being abstinent and having been in shelter-in-place for several weeks.

“The size of your notice [on the website] should be proportionate to how important it is,” Dr. Goldberg said, and the small red box on the site is easy to miss. By contrast, asking anyone to leave their homes to go to a lab for a pregnancy test in the midst of a global pandemic so they can continue their medication would be putting patients at risk, he added.

The iPLEDGE program is designed in part to ensure unplanned pregnancies do not occur in females while taking the teratogenic acne drug. But the rules are onerous and difficult even during normal times, pointed out Hilary Baldwin, MD, medical director of the Acne Treatment and Research Center in New York City and past president of the American Acne and Rosacea Society.

Male patients taking isotretinoin must visit their physician every month to get a new no-refills prescription, but females must get a pregnancy test at a Clinical Laboratory Improvement Amendments–certified lab, which must then provide physical results to the prescribing physician. The doctor enters the negative pregnancy test and the two forms of birth control the patient is taking in the iPLEDGE program site.

Then the patient must take an online test at home to acknowledge they understand what it means to not get pregnant and enter the two forms of birth control they are using – which must match what the doctor enters – before the pharmacy can dispense the drug. The entire process must occur within 7 days or else the patient has to wait 19 days before starting the process over.

“We run a very tight schedule for girls. And every month, we would worry that something would interfere, a snow storm or something else, and that they wouldn’t be able to complete their objectives within the 7-day period,” Dr Baldwin said in an interview. “It was always difficult, and now with us not being able to see the patient and the patient not wanting to go to the lab, this became completely impossible.”

Until this change, some patients may not have been able to get their prescription for severe nodulocystic acne, which can cause physical and psychological scarring, and “postponing treatment increases the likelihood of scarring,” Dr. Baldwin pointed out.