- By Colette Gallagher
Expanded Access Program for Convalescent Plasma discontinues enrollment as FDA authorizes its emergency use
ROCHESTER, Minn. — The Food and Drug Administration (FDA) authorized emergency use of convalescent plasma and the national Expanded Access Program (EAP) for convalescent plasma led by Mayo Clinic announced its intention to discontinue enrollment. The five-month program served 2,780 hospital and acute care facilities, with nearly 14,000 physicians enrolling 101,000 patients and reports of 71,000 infused so far. Eligible patients who are enrolled in the Expanded Access Program will receive convalescent plasma. For more information, go to uscovidplasma.org.
The Expanded Access Program was designed to increase access to investigational convalescent plasma and evaluate the safety of this experimental therapy. The program met those criteria. Convalescent plasma is a treatment approach that has long been used for various conditions and in some cases demonstrated improvement in health and mortality rates.
"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, M.D., lead researcher for the Mayo-led program. "Our hope is that the safety findings and possible efficacy signals could inform the body of knowledge about the use of convalescent plasma to modify the course of COVID-19. We are facilitating additional collaborative trials and scientific study of convalescent plasma."
"The program enabled possibly the largest study ever on the safety of convalescent plasma as a therapeutic option," says R. Scott Wright, M.D., a Mayo Clinic cardiologist and co-senior author of the safety study. "Additionally, the EAP was highly successful in enrolling racial and ethnic minority participants, and women — groups historically underrepresented in clinical trials. We’re grateful the data collected from the program are helping inform the FDA’s next steps."
The Expanded Access Program at Mayo Clinic grew from a national initiative of physicians and investigators from 10 institutions who self-organized to research the use of convalescent plasma during the COVID-19 pandemic.
Mayo Clinic is committed to advancing the science of medicine to ensure patients can benefit from new discoveries as quickly as possible. Mayo’s goal is to rapidly discover and apply scientific advances that will defeat this deadly disease.
This project has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services, under Contract No. 75A50120C00096. Additionally, this study was supported in part by National Center for Advancing Translational Sciences (NCATS) grant UL1TR002377; National Heart, Lung, and Blood Institute (NHLBI) grant 5R35HL139854; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5T32DK07352; Natural Sciences and Engineering Research Council of Canada (NSERC) PDF-532926-2019; National Institute of Allergy and Infectious Disease (NIAID) grants R21 AI145356, R21 AI152318 and R21 AI154927; R01 AI152078 9; National Heart Lung and Blood Institute RO1 HL059842; National Institute of Aging (NIA) U54AG044170; Eric and Wendy Schmidt; United Health Group, National Basketball Association (NBA); Millennium Pharmaceuticals, Octapharma USA Inc.; and the Mayo Clinic.
The study’s launch was followed by a national convalescent plasma donation campaign, The Fight Is In Us, supported by the CoVlg-19 Plasma Alliance, American Association of Blood Banks, American Red Cross, Grifols, Bill and Melinda Gates Foundation, Mayo Clinic, Michigan State University, Uber, and many more and promoted by celebrities including Dwayne “The Rock” Johnson, Helen Mirren, Samuel L. Jackson, Awkwafina, Ken Jeong, Daniel Dae Kim and Ryan Tedder.
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