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NIH Nixes Convalescent Plasma Covid-19 Therapy

Donated plasma

Donated blood plasma (DiverDave, Wikimedia Commons)

2 Sept. 2020. An expert panel convened by National Institutes of Health says current data do not support recommending convalescent plasma as a treatment for Covid-19 infections. The panel released its updated therapy guidelines yesterday, 10 days after the Food and Drug Administration issued an emergency use authorization for convalescent plasma to treat patients hospitalized with Covid-19 infections.

The treatment guidelines panel of university medical school faculty and U.S. government agency staff, including FDA, reviewed evidence on safety and efficacy of convalescent plasma in published and unpublished studies. Plasma is the liquid part of blood that contains antibodies produced by the immune system. The plasma from individuals who recovered from Covid-19 infections is believed to contain antibodies that can prevent or treat infections in other people.

FDA in April provided guidance for researching convalescent plasma as a Covid-19 treatment, updated in May, and encourages donations on the agency’s web site. And on 23 August, FDA issued an emergency use authorization for convalescent plasma as a treatment for confirmed or suspected infections in hospitalized patients. As pointed out by the NIH panel, an emergency use authorization from FDA is not the same as full-fledged approval, and FDA has not yet approved any treatments for Covid-19 infections.

The NIH group, known officially as the Covid-19 Treatment Guidelines Panel, highlighted three clinical trials of convalescent plasma in its report. The Mayo Clinic in Rochester, Minnesota is conducting the largest of the three trials, looking primarily at safety of the treatments, with an analysis of the first 20,000 participants published in June.

As reported by Science & Enterprise, the treatments were associated with few serious side effects. About three percent of recipients experienced serious cardiac reactions after the transfusions, and than one percent each experienced blood clots or serious transfusion reactions. The vast majority of the cardiac events and blood clots, however, were traced to patients also given hydroxychloroquine, for which FDA since revoked its emergency authorization as a Covid-19 treatment.

The two smaller trials include studies of 103 patients in Wuhan, China from February to April, and 39 patients at Mount Sinai medical center in New York in March and April. Both trials, says the panel, were limited due to the unusual conditions faced by the study teams that resulted in small numbers of participants, no blinding of treatment or control groups, or in the case of the Mount Sinai study, no randomization.

The NIH panel concludes that the clinical trial data show serious adverse effects from convalescent plasma are uncommon, but solid data on efficacy are largely missing. As a result says the panel’s report, “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19.”

The panel also notes that despite data showing few serious adverse reactions from convalescent plasma, no findings are yet available for the treatments’ long-term effects. Thus concludes the panel, “Convalescent plasma should not be considered standard of care for the treatment of patients with Covid-19.”

The panel calls as well for well-controlled randomized clinical trials to provide the high-quality data needed for decisions on convalescent plasma treatments.

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