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. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).
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 adaptive immune response that commonly include antibodies with neutralization
activity. Plasma from subjects who have recovered from viral infections has been used to both
prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP)
include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome
(MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and
observational studies of CP therapy in patients with COVID-19 have suggested a possible
clinical benefit.
Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent Plasma that contains antibody titers against SARS-CoV-2
Biological: Non-convalescent Plasma (control plasma)
Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
Inclusion Criteria:
- 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 Criteria:
- 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
1. Use of remdesivir as treatment for COVID-19 is permitted.
Columbia University Irving Medical Center/NYP
New York, New York, United States
Hospital Federal dos Servidores do Estado
Rio De Janeiro, Brazil
Hospital Geral de Nova Iguaçu
Rio De Janeiro, Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio De Janeiro, Brazil
Max O'Donnell, MD, Principal Investigator
Columbia University