COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04323800

Shmuel Shoham, MD

TOID_CRC@jhmi.edu

2020-03-27

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria subjects must be 18 years of age or older close contact exposure (as defined by cdc guidelines) to person with covid-19 within 96 hours of randomization (and 120 hours of receipt of plasma) exclusion criteria receipt of any blood product in past 120 days. medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. symptoms consistent with covid-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. laboratory evidence of covid-19 infection at time of screening. history or known laboratory evidence of previous covid-19 infection. history of prior reactions to transfusion blood products. inability to complete therapy with the study product within 24 hours after randomization.

None

2

Johns Hopkins University

18

None

United States

Close contacts to covid patients

N/A

180

Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection;Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events;Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"

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"}]