Status:
WITHDRAWN
Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19
Lead Sponsor:
Kashif Khan
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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, pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04467151
Start Date
October 1 2020
End Date
December 1 2021
Last Update
October 22 2020
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