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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kashif Khan

Criteria

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