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).
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.
Drug: anti-SARS-CoV-2 plasma
Administration of anti-SARS-CoV-2 convalescent plasma
Other Name: Convalescent Plasma
Other: Placebo
Administration of placebo (albumin 5%)
Other Name: Albumin
Inclusion Criteria:
- Patients ≥18 years of age
- Hospitalized with COVID-19-related acute respiratory symptoms
- Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3
("Hospitalized, no oxygen therapy) or 4 ("Hospitalized, on oxygen by mask or nasal
prongs")
- Laboratory-confirmed COVID-19
- First signs of infection occurring no more than 14 days prior to enrollment
Exclusion Criteria:
- Receipt of pooled immunoglobulin in the past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood
products
- Admission to intensive care unit at any point during hospital course prior to
enrollment
Kashif T Khan, MD, SM, Principal Investigator
Keck School of Medicine of University of Southern California