COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04373460

David J Sullivan, MD

dsulliv7@jhmi.edu

2020-05-04

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: ≥ 18 years of age competent and capable to provide informed consent • positive molecular test for presence of sars-cov-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab experiencing any symptoms of covid-19 including but not limited to fever(t> 100.5º f), cough, or other covid associated symptoms like anosmia ≤ 8 days since the first symptoms of covid-19 ≤ 8 days since first positive sars-cov-2 rna test able and willing to comply with protocol requirements listed in the informed consent

hospitalized or expected to be hospitalized within 24 hours of enrollment psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance history of prior reactions to transfusion blood products inability to complete therapy with the study product within 24 hours after enrollment receiving any treatment drug for covid-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). steroid treatment at any time does not affect study eligibility

2

Johns Hopkins University

18

None

United States

Mild disease at enrollment

1: Mild disease at enrollment

1225

Cumulative Incidence of Severe Infusion Reactions;Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS);Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events;Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization

None

Phase 2

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