Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19

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.

• anti-SARS-CoV-2 plasma (Drug), also known as Convalescent Plasma: Administration of anti-SARS-CoV-2 convalescent plasma
• Placebo (Other), also known as Albumin: Administration of placebo (albumin 5%)

Primary outcomes

• Disease progression measured by WHO scale [Day 0 through Day 28 (or hospital discharge)]: Disease progression from the state at randomization (with a "3" or "4" on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is "6" or greater on the WHO scale) during the study period

Secondary outcomes

• Comparison of maximum WHO score per group [Day 0 through Day 28 (or hospital discharge)]: Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group
• Comparison of decrease of median and maximum WHO score per group [Day 0 through Day 28 (or hospital discharge)]: Comparison of the median and maximum daily WHO scores during the study period per group
• Comparison of time to clinical improvement per group [Day 0 through Day 28 (or hospital discharge)]: Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale "2" first reached for at least 1 day)
• Comparison of time to reach score of "6" or greater on the WHO scale [Day 0 through Day 28 (or hospital discharge)]: Evaluate the time to reach score of at least 6 within 28 days

Other outcomes

• Comparison of hospital length of stay per group [Day 0 through Day 28 (or hospital discharge)]: Evaluate number of days hospitalized
• Comparison of ICU length of stay per group [Day 0 through Day 28 (or hospital discharge)]: Evaluate number of hours in the ICU

Sex: All, ages: 18 Years to any

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

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• Kashif T Khan, MD, SM, Principal investigator, Keck School of Medicine of University of Southern California