COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04359810

Max O'Donnell, MD

mo2130@cumc.columbia.edu

2020-04-24

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Max O'Donnell

18

None

Brazil;United States

Severe disease at enrollment

6: Severe disease at enrollment

223

Day 28 severity outcome

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]