Convalescent Plasma to Stem Coronavirus (CSSC-001)

Phase 2

Completed

• Conditions: Convalescence; Coronavirus

• Registration Number: NCT04323800
• Lead Sponsor: Johns Hopkins University

Brief Summary

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Detailed Description

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2020-06-10
• Primary Completion: 2021-04-22
• Study Completion: 2021-06-22
• Status Verified: 2022-04
• Results First Submitted: 2022-04-20
• Results First Submitted QC: 2022-04-20
• Results First Posted: 2022-04-22
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection	Day 28	Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"	Up to Day 28	Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
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	Up to Day 28	Cumulative incidence of grade 3 and 4 adverse events during the study period evaluated as events per 100 person-years will be used to assess safety of the intervention.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Severe Disease	Up to 28 days	Number of participants with severe disease between the anti-SARS-CoV-2 convalescent plasma and control groups. Severity of disease will be measured using the number of participants with any of the disease severity categories below: 1. Death; 2. Requiring mechanical ventilation and/or in ICU; 3. non-ICU hospitalization, requiring supplemental oxygen; 4. non-ICU hospitalization, not requiring supplemental oxygen

Trial Locations

Locations (25)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Center for American Indian Health - Whiteriver Office; 🇺🇸 Whiteriver, Arizona, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of California, Irvine Health; 🇺🇸 Orange, California, United States

Western Connecticut Health Network, Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

Western Connecticut Health Netowrk, Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Coral Gables, Florida, United States

University of Miami Clinical Translational Research Site; 🇺🇸 Miami, Florida, United States

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