Mayo Clinic researchers and collaborators have found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 hospitalized patients transfused with investigational convalescent plasma as part of the U.S. Food and Drug Administration’s national Expanded Access Program (EAP) for COVID-19.
The safety report assessed the seven days following transfusion for hospitalized patients between April 3 and June 11, 2020, who were deemed at risk of progressing to a severe or life-threatening condition. This update provides safety data from 20,000 patients, including the initial 5,000 and subsequent 15,000 transfused patients. Data from the first 5,000 transfused patients were reported previously. The safety update highlights include:
- Seven-day mortality rates declined to 8.6 % compared to 12% in a previous safety study of the first 5,000 transfused patients.
- The recruitment of a diverse population has improved over the course of the study. Nearly 40% of study participants were women; 20% African Americans; with nearly 35% Hispanic and 5% Asian.
- Reports of serious adverse events related to transfusion of the plasma continues to be less than 1%.
- Seven-day mortality rates declined after 20,000 transfused patients, providing robust evidence that investigational convalescent plasma is safe for patients with COVID-19 and has no excess risk of complications.
- The study was not designed to evaluate the efficacy of convalescent plasma. This safety report does not provide any findings on the effectiveness of convalescent plasma in the treatment of COVID-19.