NIH Expands Trials of Convalescent Plasma for COVID-19

The National Institutes of Health (NIH) yesterday announced the expansion of two late-stage trials of convalescent plasma in the wake of the FDA’s Emergency Use Authorization (EUA) for the investigational COVID-19 treatment.

Following the FDA’s authorization, the NIH’s COVID-19 Treatment Guidelines Panel said there was not enough data to say if convalescent plasma should be recommended or rejected as a COVID-19 treatment (DID, Sept. 3).

The panel’s decision followed widespread criticism of FDA Commissioner Stephen Hahn, who had misrepresented convalescent plasma’s effectiveness during the White House’s announcement of the EUA. Hahn later apologized for the error (DID, Aug. 26).

One expanded phase 3 trial will double the number of participants from 500 to 1,000 across 50 trial sites. Launched by Vanderbilt University Medical Center in April, the trial is looking for any clinical improvement 15 days into treatment.

A separate phase 2 trial is looking into convalescent plasma’s impact 14 and 28 days into treatment. Launched in April by NYU Langone Health, the Albert Einstein College of Medicine and Yale University, the trial is expanding to the University of Texas Health Science Center and the University of Miami. It will now enroll approximately 1,000 hospitalized COVID-19 patients, up from its original target of 300 participants. — Jordan Williams