May 23, 2020
- Updated protocol document (version 6.0). Removed reference to ABO throughout protocol and added new section 4.4 to define preference of ABO compatibility. Updated Dose justification of volume of convalescent plasma in section 4.3, 5.2, 7.1 and 6.1.2.
- Updated English consent form
- New FAQ regarding change for ABO compatible convalescent plasma
- Updated FAQ outlining number of units and rate of transfusion, along with reporting requirements
About this program
Responding to the unprecedented challenge of fighting coronavirus disease 2019 (COVID-19), the U.S. Government is supporting a national Expanded Access Program to collect and provide convalescent plasma to patients in need across the country. Plasma from recovered COVID-19 patients contains antibodies that may help fight the disease.
Working collaboratively with industry, academic, and government partners, Mayo Clinic will serve as the lead institution for the program.
People who recover from COVID-19 do so, at least in part, because their blood contains substances called antibodies, which are capable of fighting the virus that causes the illness. It turns out that for some other diseases caused by viruses, giving people the liquid portion of blood (plasma), obtained from those who have recovered from the virus, leads to more rapid improvement of the disease. Patients with COVID-19 may improve faster if they receive plasma from those who have recovered from COVID-19, because it may have the ability to fight the virus that causes COVID-19.
Initial data available from studies using COVID-19 convalescent plasma for the treatment of individuals with severe or life-threatening disease indicate that a single dose of 200 mL showed benefit for some patients, leading to improvement.
COVID-19 convalescent plasma has not yet been demonstrated to provide clinical benefit in patients affected by this disease. It's not known if this treatment will or will not help those with COVID-19 or if it will have any harmful effects, but this is one of the only treatments that we have at present.
Following registration on the protocol in one of the participating centers and provision of informed consent, patients will be given a transfusion with one unit of ABO-compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2.
Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma.
Patients are free to withdraw consent from participation in further data collection at any time during the study by informing their health care provider.
For more information about the Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 protocol, please contact:
Michael Joyner, M.D.
Principal InvestigatorMayo Clinic
200 First St. SW
Rochester, MN 55905 View Bio