There is no strong evidence for or against the recommendation of convalescent plasma to treat hospital patients with COVID-19, a government panel said on Tuesday, less than 10 days after the Food and Drug Administration cleared it. emergency use of treatment.
The COVID-19 Treatment Guidelines Panel, part of the National Institutes of Health, said it had reviewed all available research on convalescent plasma, including the FDA analysis that led to its authorization for use. emergency.
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“There are currently no data from well-controlled and sufficiently powerful randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” the group wrote online.
Dr Eric Topol, director of the Scripps Research Translational Institute in California, tweeted that this was an “important” statement. Topol has previously criticized the FDA’s emergency use authorization for convalescent plasma.
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The data cited by the FDA was based on a preliminary study of convalescent plasma from the Mayo Clinic, which compared a small subset of patients who received a high or low concentration of COVID-19 antibodies in plasma. The study suggested some benefit for patients who were sick enough to be hospitalized but who had not been placed on ventilators. However, there was no significant difference in the death rates.
Another small study from China, published in August in the Journal of the American Medical Association, mirrored Mayo research. It did not show that plasma helps people survive COVID-19, but it does suggest clinical improvement in a specific group of patients: those who were in the hospital and had difficulty breathing but had failed. not yet deteriorated to the point of needing fans.
“For me, that’s enough to recommend it, pending further studies,” said Dr. Hugh Cassiere, director of intensive care services at Sandra Atlas Bass Heart Hospital at North Shore University Hospital, part of Northwell Health. , in Long Island, New York. Cassiere said he administered convalescent plasma to “dozens” of COVID-19 patients in his intensive care unit.
More than 72,000 patients with COVID-19 in the United States have been treated with convalescent plasma. However, the committee said that “convalescent plasma should not be considered a standard treatment” until more robust studies are completed – especially randomized, placebo-controlled clinical trials, which are considered the gold standard because they assess whether a treatment is working by comparing it to a placebo.
These studies are continuing, but have had difficulty enrolling participants. Convalescent plasma is considered safe and is available to physicians desperate for anything that could help patients.
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Cassiere said he would continue to use convalescent plasma on his critically ill patients if necessary, despite the new NIH statement.
“I have to treat the patients right away. I can’t wait three to six months for an article to appear. My patients would be dead by then, ”he said.
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