Plasma Therapy of COVID-19 in Severely Ill Patients
Completed · Phase 2
Conditions studied: SARS-CoV-2 Infection
In brief
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).
Key facts
- Study ID
- NCT04359810
- Run by
- Max O'Donnell
- People needed
- 223
- Starts
- 2020-04-21
- Expected to finish
- 2020-12-30
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.