This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.~After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.
The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).