Overall study design~This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.~Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.~Subjects will be randomized to receiving convalescent plasma or best supportive care.~Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.~The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.~A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician.~Overall study duration~The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).~The expected duration of the study is approximately 12 months.
This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.~Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.~Subjects will be randomized to receiving convalescent plasma or best supportive care.~Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.~The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.