Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19

Emerging infectious diseases such as the Coronavirus disease 2019 (COVID-19) pandemic cause substantial morbidity and mortality. During the early emergent phases of such diseases, there is often no vaccine to prevent infection, nor specific therapeutic agent to treat the disease. The objective of this protocol is the collection of immune plasma from persons post-recovery from COVID-19 or vaccination against SARS-CoV-2. This plasma may potentially be used in the treatment or prophylaxis of active COVID-19 under other protocols. Candidates will be screened for eligibility to participate in plasma donations and their blood levels of antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline physical and laboratory examination. Subjects with sufficient anti-SARS-CoV-2 antibody titers who meet standard blood bank criteria for plasma donation will then be scheduled for plasma collections. Plasmapheresis is the preferred method of collection, with up to 800 mL of plasma collected per donation depending on the weight of the donor. Collected immune plasma will be tested for blood-borne pathogens, and stored according to standard blood bank procedures. The scope of this protocol is limited to collection of plasma from subjects with sufficiently high anti-SARS-CoV-2 antibody titer. Any administration of convalescent immune plasma to subjects will be performed under a separate protocol.