NIH halts COVID-19 convalescent plasma trial, renewing calls for FDA to withdraw authorization

NIH announced Tuesday that it has halted a trial of COVID-19 convalescent plasma to treat emergency department patients who developed mild-to-moderate symptoms of COVID-19 because there was no evidence of efficacy. The move renewed calls for FDA to withdraw or reconsider its emergency use authorization (EUA) of convalescent plasma, raises questions about the future of large-scale expanded access programs for the therapy, and provides lessons for responding to future public health emergencies.

NIH launched the Clinical Trial of COVID-19 Convalescent Plasma of Outpatients (C3PO) in August 2020 at a time when there was a surplus of enthusiasm for the therapy and a paucity of data about its safety or efficacy. ...