Hospitals wary of FDA guidance on plasma treatments for coronavirus

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Doctors are considering joining a clinical trial to test the effectiveness of convalescent plasma treatment against the coronavirus rather than relying on government guidance that allows a broader emergency use of the technique right now.

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Despite the Food and Drug Administration's permission in August to use convalescent plasma on COVID-19 patients, doctors remain concerned that science doesn't fully back the effectiveness of the treatment and worry that President Trump pressured the agency into approving its usage.

Trump praised the “powerful therapy," which has been administered to more than 77,000 COVID-19 patients in the U.S., but scientists from the National Institutes of Health declared that it “should not be considered the standard of care for the treatment of patients with COVID-19,” and pushed for more testing.

Data so far suggests the treatment could be beneficial, but it’s not definitive.

“It’s an important scientific question that we don’t have the answer to yet,” Dr. Todd Rice, director of Vanderbilt University Medical Center's intensive care unit, which is spearheading further clinical trials of the method, told Kaiser Health News.

The trial, backed with funding from country megastar Dolly Parton as well as $34 million from the NIH, plans to inject antibody-rich plasma from the blood of previously infected COVID-19 patients into 500 hospitalized patients grappling with the virus.

The study aims to have 1,000 participants -- with 500 being given a placebo -- and will assess whether the treatment triggers an immune response to fight the virus, a tactic used successfully against other virulent diseases, such as the 1918 flu, measles, Ebola, SARS and H1N1 influenza.

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The study has struggled to gain traction and lacks participants, but some 45 hospitals across the country have expressed interest in putting their resources toward the clinical trials.