Status:
COMPLETED
Plasma Therapy of COVID-19 in Severely Ill Patients
Lead Sponsor:
Max O'Donnell
Collaborating Sponsors:
New York Blood Center
Amazon, Inc.
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate...
Detailed Description
There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adap...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
- Age ≥18 years
- Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
- Evidence of infiltrates on chest radiography
- Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.
Exclusion
- Participation in another clinical trial of anti-viral agent(s) for COVID-19
- Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 \<24 hours prior to study drug administration \[1\]
- Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
- Severe multi-organ failure
- History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
- Known Immunoglobulin A (IgA) deficiency
- Females who are pregnant
- Use of remdesivir as treatment for COVID-19 is permitted.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT04359810
Start Date
April 21 2020
End Date
December 30 2020
Last Update
September 19 2024
Active Locations (4)
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1
Columbia University Irving Medical Center/NYP
New York, New York, United States, 10032
2
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Brazil
3
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Brazil
4
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, Brazil