Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A total of approximately 1344 eligible subjects stratified 50:50 in the <65 vs ? 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19...
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified 50:50 in the <65 vs ? 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Tracking Information
- NCT #
- NCT04373460
- Collaborators
- State of Maryland
- Bloomberg Foundation
- United States Department of Defense
- National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- Principal Investigator: David J Sullivan, MD The Johns Hopkins University
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