Hospitals Torn Between Emergency Use of Blood Plasma Versus Clinical Trials

The FDA’s Aug. 23 Emergency Use Authorization (EUA) for convalescent plasma to treat COVID-19 has left hospitals with a choice — give the treatment to individual patients under the EUA or enroll them in clinical trials that will help settle the question of the treatment’s safety and efficacy.

Dozens of U.S. hospitals are looking into the latter option and considering entering a phase 3 study, according to Wesley Self, a principal investigator in the Passive Immunity Trial of the Nation for COVID-19.

That phase 3 trial began at the Vanderbilt University Medical Center in Nashville, Tenn., in late April with funding from country singer Dolly Parton. Last month it expanded nationally with a $34 million grant from the National Institutes of Health (NIH). Between 30 and 50 hospitals have expressed interest in entering the trial, Self said.

“Many, many thousands of people have been treated with convalescent plasma, and we still don’t understand if it works,” he said. The Vanderbilt study aims to enroll 500 participants for the year-long trial.

The FDA last week updated its guidance on convalescent plasma for COVID-19 in light of the EUA, saying that “ongoing clinical trials of investigational convalescent plasma should not be amended based on the issuance of the EUA” (DID, Sept. 4).

Also last week, the NIH said there are not enough data to say if it should recommend or reject convalescent plasma as a COVID-19 treatment and called for more randomized, controlled trials (DID, Sept. 3).

Meanwhile, one site, Ohio State University’s Wexner Medical Center (WMC), was working on a trial for convalescent plasma before the EUA was announced, and the authorization “made the policy [of entering a trial] even stronger,” according to Sonal Pannu, an assistant professor of pulmonary clinical care medicine at the center.

She said the WMC trial, which will get under way within weeks, will be the “the first option for patients” and those who cannot make the trial will be treated under the EUA. — Jordan Williams