Expanded Access Program for Convalescent Plasma discontinues enrollment as FDA authorizes its emerge
Sunday, August 23, 2020
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Expanded Access Program for Convalescent Plasma discontinues enrollment as FDA authorizes its emergency use
August 23, 2020 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. ### About Mayo Clinic
Mayo Clinic is
a nonprofit organization committed to innovation in clinical practice,
education and research, and providing compassion, expertise and answers
to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news and Mayo Clinic Facts for more information about Mayo. Media contact:
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