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Monday, May 4, 2020

Mysterious coronavirus condition ‘happy hypoxia’ baffles doctors

A strange phenomenon dubbed “happy hypoxia” has baffled doctors treating coronavirus patients who describe themselves as comfortable despite dangerously low oxygen levels that would typically leave them unconscious, or even dead, according to reports.
The mysterious condition that appears to defy basic biology is raising questions about how COVID-19 attacks the lungs, the Guardian reported.
While a healthy person’s blood-oxygen saturation is at least 95 percent, doctors have reported some coronavirus-stricken patients with levels in the 80s or 70s — with some extreme cases below 50 percent, according to the outlet.
And yet these so-called “happy hypoxics” have been observed scrolling on their phones, chatting with their health care providers and describing themselves as generally comfortable, Science Magazine reported.
“There is a mismatch [between] what we see on the monitor and what the patient looks like in front of us,” Dr. Reuben Strayer, an emergency physician at Maimonides Medical Center in Brooklyn, told the magazine from his home as he recovered from the illness himself.
Strayer said he and other doctors are seeking to understand the odd condition, which he first noticed in March as patients streamed into his ER, and how to treat it.
Dr. Jonathan Bannard-Smith, a critical care specialist at the Manchester Royal Infirmary in the UK, told the Guardian that some patients are unaware that their oxygen saturations are so low.
“We wouldn’t usually see this phenomenon in influenza or community-acquired pneumonia,” he said. “It’s very much more profound and an example of very abnormal physiology going on before our eyes.”
He added: “It’s intriguing to see so many people coming in, quite how hypoxic they are.”
Another British physician said people would ordinarily appear to be extremely ill with other lung conditions that could cause severe hypoxia.
“With pneumonia or a pulmonary embolism they wouldn’t be sat up in bed talking to you,” Dr. Mike Charlesworth of Wythenshawe hospital in Manchester told the Guardian.
“We just don’t understand it. We don’t know if it’s causing organ damage that we’re not able to detect. We don’t understand if the body’s compensating,” added the doctor, who also was infected with COVID-19.
After coming down with a cough and fever, he spent 48 hours in bed, during which he said there were signs he was hypoxic.
“I was sending very strange messages on my phone. I was essentially delirious. Looking back, I probably should’ve come into hospital. I’m pretty sure my oxygen levels were low,” he told the news outlet.
“My wife commented that my lips were very dusky. But I was probably hypoxic and my brain probably wasn’t working very well,” he added.
What causes people suffering from lung diseases to feel breathless is not the fall in oxygen levels but rather the body sensing the rising levels of carbon dioxide.
“The brain is tuned to monitoring the carbon dioxide with various sensors. We don’t sense our oxygen levels,” Paul Davenport, a respiratory physiologist at the University of Florida, told Science Magazine.
But among some coronavirus patients, this response does not appear to be kicking in.
During the early phase of COVID-19, low saturation levels aren’t always accompanied with obvious respiratory difficulties.
Carbon dioxide levels can be normal, and deep breathing may be comfortable, Dr. Elnara Marcia Negri, a pulmonologist at Hospital Sírio-Libanês in São Paulo, Brazil, told the magazine.
“The lung is inflating so they feel OK,” she said, though their oxygen saturation can be in the 70s, 60s, 50s or even lower.
Theories about what causes “happy hypoxia” are emerging, as many doctors recognize clotting as a major feature of severe COVID-19.
Negri believes slight clotting might start early in the lungs, perhaps a result of an inflammatory reaction in their fine blood vessels, which could trigger a cascade of proteins that prompts blood to clot.
Strayer also finds it reasonable to imagine that hypoxia may be caused when “small blood vessels of the lung are being showered with clots.”
His hospital and others are beginning to test many coronavirus patients for markers of excess clotting and treat those who show it with blood thinners. Science Magazine reported.
But Strayer stressed that “it is simply not known” whether clotting causes “happy hypoxia.”
Recent imaging of a hypoxic patient showed “almost waxy-looking film all around the lungs,” Caputo said. “I don’t know what is actually going on pathophysiologically down there.”
https://nypost.com/2020/05/04/mysterious-coronavirus-effect-happy-hypoxia-baffles-doctors/

Gottlieb questions accuracy of antibody tests: ‘I’d repeat it three times’

Former FDA Commissioner Scott Gottlieb on Monday warned about the accuracy of antibody tests that show whether someone has had the coronavirus, saying he would take a test three times to be sure of the results.
“If you do go out and get an antibody test and you get a positive result meaning you have the antibodies, I would suggest you repeat it, because there’s such a high false positive rate, meaning the tests say you have antibodies when you don’t, that I wouldn’t put any stock in any single result,” Gottlieb said on CNBC.
“Quite frankly if it was me, I’d repeat it three times, I know they’re expensive, but I wouldn’t put confidence in any one test,” he added.
Antibody tests determine whether has had the coronavirus in the past by testing for the presence of antibodies in the blood, making them different from tests that determine whether someone is currently infected with the virus.
Some experts have suggested that antibody tests can help some people return to work if they are shown to have the antibodies and therefore have some level of immunity to the virus. But the problems with the accuracy of the tests complicate that effort.
The FDA on Monday moved to try to increase its oversight, saying that antibody tests would need to receive emergency authorization from the FDA. That could help put more control over the more than 100 tests on the market.
Gottlieb said a more fruitful use for resources is not more individual-level tests, but rather for researchers to determine roughly what percentage of a given population has had the virus.
If someone does obtain multiple positive antibody results, Gottlieb said, “I think you can be reasonably confident that you have a level of immunity.”
“Now how long that lasts we’re unsure,” he added. “It’s probably going to be months, it might be a year or more.”
https://thehill.com/policy/healthcare/495966-gottlieb-questions-accuracy-of-antibody-tests-id-repeat-it-three-times

CVS says it will boost access to mental health services

CVS Health said it will increase access to mental health services to help flatten “the second curve” of the COVID-19 pandemic.
The company said the second wave of the pandemic is an escalating mental health crisis, particularly among front-line responders.
“The wrath of COVID-19 is not just physical. Mental trauma is the deadly undertow of the pandemic’s first wave. The impact of isolation, fear, uncertainty and loss can be just as deadly as the virus itself,” said Karen Lynch, CVS Health’s executive vice president.
CVS Health said it has seen a 200 percent increase in virtual mental health visits since March compared to the year before, as well as substantial increases in calls for help with psychological distress.
In response, it is donating $500,000 to Americares, which helps front-line healthcare workers, particularly those with low incomes, improve their mental health awareness, knowledge and resiliency.
It is also donating $300,000 to a crisis text line called For the Frontlines, which provides mental health support for front-line workers, and $220,000 to Give An Hour, which offers free counseling to healthcare workers.
Read the full news release here.
https://www.beckershospitalreview.com/pharmacy/cvs-says-it-will-boost-access-to-mental-health-services.html

COVID-19 patients most infectious before, right after symptom onset

Transmission of COVID-19 is high before and immediately after symptoms begin to show in a person infected with the new coronavirus, a study published in JAMA Internal Medicine shows.
For the study, researchers examined 100 initial patients with confirmed cases of COVID-19 and their contacts in Taiwan. They studied 2,761 close contacts of the 100 initial cases. All close contacts were quarantined at home for 14 days after their last exposure to the initial case.
The overall secondary clinical attack rate (that is, rate of new cases among close contacts) was 0.7 percent.
Researchers found that the attack rate was higher among the 1,818 contacts who were exposed to the initial COVID-19 patients within five days of symptom onset, compared to those who were exposed later. The 299 contacts exposed to the initial COVID-19 patients before their symptoms began were also at higher risk of infection.
“In this study, high transmissibility of COVID-19 before and immediately after symptom onset suggests that finding and isolating symptomatic patients alone may not suffice to contain the epidemic, and more generalized measures may be required, such as social distancing,” researchers wrote.
https://www.beckershospitalreview.com/infection-control/covid-19-patients-most-infectious-before-right-after-symptom-onset-study-finds.html

Access to quick testing ‘extremely challenging’ for US healthcare – survey

A little over a third of healthcare leaders and clinicians said that access to quick, timely testing has been “extremely challenging” for U.S. healthcare organizations, according to results of a new survey.
The survey, conducted in April, includes responses from 522 from members of the NEJM Catalyst Insights Council, a group of executives, clinical leaders, and clinicians at organizations directly involved in healthcare delivery in the U.S.
Five survey results:
1. Thirty-six percent of respondents said that access to quick, timely testing has been “extremely challenging” for healthcare organizations, while 8 percent said access has not been challenging or not very challenging.
2. About 51 percent of respondents said that getting enough personal protective equipment has been “extremely” or “very” challenging.
3. Twenty-eight percent said getting enough intensive care beds has been at least very challenging.
4. Most respondents (57 percent) said that their organization’s leadership has responded very or extremely effectively to the COVID-19 pandemic.
5. About 21 percent of respondents said that their organization’s external communications about COVID-19 have been “fair” or “poor.”
https://www.beckershospitalreview.com/hospital-management-administration/access-to-quick-testing-extremely-challenging-for-us-healthcare-survey-shows.html

New CMS panel seeks answers for nursing homes fighting coronavirus

CMS has created an independent commission to make recommendations for responding to the COVID-19 pandemic in nursing homes.
The commission will include clinicians, resident/patient advocates, medical ethicists, administrators, infection control and prevention professionals as well as state and local authorities, among others. It is expected to convene later this month and develop recommendations in three key areas:
● Protecting nursing home residents from COVID-19 and improving the responsiveness of care delivery
● Strengthening efforts to identify and curb COVID-19 transmission in nursing homes
● Enhancing strategies to improve infection control compliance in response to COVID-19
The panel also will focus on finding new ways to use nursing home data to allow for better coordination between federal surveyors, state and local entities and nursing homes.
https://www.beckershospitalreview.com/post-acute-care/new-cms-panel-seeks-answers-for-nursing-homes-fighting-coronavirus.html

Roche takes on Abbott in Covid-19 antibody testing

Robust specificity data mark Roche’s serological test out as a major competitor.
Roche has become the latest company to gain FDA emergency use authorisation for a Covid-19 antibody blood test, and the accuracy claims the Swiss group makes for the assay suggest it is very competitive with Abbott’s rival product.
Roche claims sensitivity of 100% and specificity of more than 99.8% when an individual is tested two weeks after a PCR test has diagnosed an active Covid-19 infection. This beats – though only by the slimmest margin – the figures Abbott released for its test, which was launched in the US in mid-April, without an EUA. It finally got the FDA’s buy-in last week, though it only obtained EUA last Tuesday.
The Elecsys anti-Sars-CoV-2 antibody test works on Roche’s cobas e range of analysers, more than 40,000 of which are installed around the world and which can run up to 300 tests an hour. Roche has already started shipping the test, which is also CE marked, and says it can ramp up production capacity to “high double-digit millions” per month.
The Elecsys assay is the ninth serological test to have gained an EUA from the FDA, but the quality of the evidence for their accuracy – specificity is particularly important – varies (Covid-19 antibody tests face a very specific problem, April 22, 2020).
Evidence
Roche assessed its test’s sensitivity on 204 samples from 69 symptomatic patients with a PCR-confirmed Covid-19 infection. But only 29 samples were from the 14-day time point, a smallish dataset, though to be fair the assay correctly flagged them all.
Still, specificity is the crucial point, and here the Elecsys test acquitted itself well, and in a much larger cohort. It was used to test 5,272 blood samples taken from routine diagnostic testing, blood donors, a common cold panel, and a coronavirus panel comprising 40 potentially cross-reactive samples from individuals with past infection with non-Covid-19 coronaviruses. All of these samples were obtained before December 2019 and thus could not carry the Covid-19 virus. 10 of the samples came back positive, giving a specificity of 99.81%.
Accuracy figures for selected Covid-19 antibody tests 
Company Test name Date of US EUA EU status Sensitivity (%) Specificity (%)
Cellex Cellex qSars-CoV-2 IgG/IgM cassette rapid test Apr 1 Unknown 93.8 95.6
Ortho-Clinical Diagnostics Vitros anti-Sars-CoV-2 total reagent pack Apr 14 Unknown 83.3 100.0
Diasorin Liaison Sars-CoV-2 S1/S2 IgG test Apr 24 CE marked 97.4 98.5
Ortho-Clinical Diagnostics Vitros anti-Sars-CoV-2 IgG reagent pack Apr 24 Unknown 87.5 100.0
Autobio Diagnostics Anti-Sars-CoV-2 rapid test (IgM and IgG) Apr 24 Unknown 93.0 100.0
Abbott Laboratories Abbott Sars-CoV-2 IgG test Apr 26 CE marked 100.0 99.5
Bio-Rad Laboratories Platelia Sars-CoV-2 total Ab assay Apr 29 CE marked 98.0 99.0
Roche Elecsys anti-Sars-CoV-2 antibody test May 3 CE marked 100.0 99.8
Note: All accuracy claims made by the companies. Includes only tests with FDA emergency use authorisation. 
There is one last thing to remember, however, when considering the potential of these assays to permit the reopening of businesses, offices and schools. There is still no definite proof that the presence of antibodies to Sars-CoV-2 does in fact confer immunity to subsequent infection by this virus in humans.
https://www.evaluate.com/vantage/articles/news/policy-and-regulation/roche-takes-abbott-covid-19-antibody-testing