July 10, 2020
- Reminder: You can always contact USCOVIDplasma@mayo.edu with any questions about the expanded access program.Amended protocol document posted.
- Option number 3 has been updated under “Are there alternatives to obtaining written consent from patients” on the protocol & consent page.
- Advance notice: Due to a mandatory software upgrade, program forms will not be accessible from 7-7:30 a.m. Central time, on Saturday, July 18, 2020. There should be no noticeable change to the forms due to the upgrade. If you encounter any difficulties, contact USCOVIDplasma@mayo.edu.
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 one or more transfusions 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