This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares
standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will
be collected from all participants at eight timepoints, and clinical data will be collected
for 30 days or until discharge/death.
Biological: Thawed plasma
Plasma not labeled "convalescent plasma" is presumed to be free of COVID antibodies, but is not tested for antibodies. To ensure that we are using antibody-free plasma, we will test each unit of plasma with a quick COVID test before it is utilized in this study.
Inclusion Criteria:
- 18 years of age or older
- COVID-19 positive by PCR or assay within 72 hours or less
- Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening
Exclusion Criteria:
- mechanically ventilated
- pregnant
- prisoners
- receiving resuscitation with blood products for hemorrhagic shock
- receiving an investigational therapy for COVID-19
- diagnosed with severe comorbidities
- not expected to survive more than 24 hours
Rondi Gelbard, MD, Principal Investigator
University of Alabama at Birmingham