BARDA has entered into a collaboration with Mayo Clinic to support an expanded access program to provide access to convalescent plasma for patients hospitalized with COVID-19. Expanded access programs allow access to pre-approved drugs and therapeutic treatments such as convalescent plasma outside of a clinical trial setting. In this way, the expanded access program provides a framework for rapid access to a potential therapy for COVID-19.
Individuals who recover from infections likely developed antibodies as part of their own immune response. These antibodies have the potential to bind the virus and neutralize it. Plasma containing antibodies can be collected from recovered individuals, and transfused into patients with active disease. Because this approach is simpler than developing an entirely new product, plasma can be used in clinical trials or under expanded access programs faster than new therapeutics or vaccines.
Mayo Clinic is serving as the central Institutional Review Board (IRB) to oversee the expanded access program which includes patients at multiple hospitals across the country. This approach allows for rapid access when timing and access to potential life saving treatments is critical.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.