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

Kashif Khan

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

COVID-19

Interventions

anti-SARS-CoV-2 plasmaDRUG

Administration of anti-SARS-CoV-2 convalescent plasma

PlaceboOTHER

Administration of placebo (albumin 5%)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Disease progression measured by WHO scale

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