For five months, the Mayo Clinic used its Expanded Access Program to investigate and evaluate the safety of the experimental COVID-19 therapy. Mayo says the treatment “demonstrated improvement in health and mortality rates” in “some cases” of COVID-19.
2,780 hospital and acute care facilities, 14,000 physicians and 101,000 patients were enrolled in the Mayo Clinic’s program. 71,000 were infused with the treatment.
“While the program was never intended to be a randomized clinical trial, in the course of our work, Mayo Clinic and our collaborators observed potential signals of efficacy among a diverse population and chose to share those data,” says Michael Joyner, a lead researcher for the Mayo-led program.
Dr. R. Scott Wright, a Mayo cardiologist, said the program enabled “possibly the largest study ever on the safety of convalescent plasma as a therapeutic option.”
Mayo’s EAP program also saw success in enrolling racial and ethnic minority participants and women, who are all historically underrepresented in clinical trials, Wright added.