The NIH announced today that it has halted a clinical trial of COVID-19 convalescent plasma among ER patients with mild-to-moderate symptoms after the trial found no significant benefit from the treatment.
An independent data and safety monitoring board (DSMB) recommended on Feb. 25 that NIH’s stop enrolling new patients. The Clinical Trial of COVID-19 Convalescent Plasma of Outpatients — which had already enrolled 511 participants from 47 hospital emergency departments across the U.S. — found no harm from convalescent plasma. Still, there was no significant difference in hospitalization and death rates among those receiving the plasma and those receiving a placebo.
FDA in August 2020 granted an emergency use authorization (EUA) for investigational convalescent plasma in treating hospitalized COVID-19 patients, noting at the time that the plasma might help some hospitalized patients. More than 100,000 people in the United States have received survivor’s plasma,” according to NIH. The plasma contains antibodies, or protective proteins, generated by the body’s immune system to the novel coronavirus.
Filed Under: clinical trials, Drug Discovery, Infectious Disease