Mayo Clinic will be the lead institution providing coordinated access to investigational convalescent plasma for hospitalized patients with severe or life-threatening COVID-19, or those at high risk of progression to severe or life-threatening disease. The Food and Drug Administration (FDA) announced the designation on Friday, April 3.
Convalescent plasma refers to blood plasma collected from people who have recovered from COVID-19. That plasma is then used to treat others with advanced illness. The plasma donor must have recovered from, and tested negative for, COVID-19 and be otherwise healthy. The patient is transfused with the donor's plasma, which contains antibodies that can attack the virus and may help patients recover more rapidly.
The convalescent plasma program at Mayo Clinic, which is led by researcher Michael Joyner, M.D., grew from a national initiative of physicians and investigators from 40 institutions who self-organized to investigate the use of convalescent plasma during the COVID-19 pandemic. These institutions include Mayo Clinic, Johns Hopkins University, Washington University, Einstein Medical Center, Icahn School of Medicine at Mount Sinai, Michigan State University, as well as countless other academic medical centers and government agencies seeking to establish a national convalescent plasma program to modify the course of disease.
"We are pleased to work with our colleagues and the nation to fight this pandemic every way we can as part of Mayo's patient-focused mission," Dr. Joyner says. "We believe this program, in extending access to this investigational treatment, is a hopeful therapeutic option. We anticipate a trickle of convalescent plasma for therapy will begin next week, with more available in the following weeks. We also will collect data so we can understand how best to use plasma to treat COVID-19."
Physicians at any institution who are treating hospitalized patients with COVID-19 can register their patients' information at uscovidplasma.org. The national program is supported by the American Red Cross and the larger blood-banking community, which will work with physicians to collect and distribute the donor plasma.
The FDA authorized the Convalescent Plasma Expanded Access Program for the use of convalescent plasma for patients infected with SARS-CoV-2, the virus that causes COVID-19