Convalescent Plasma to Stem Coronavirus (CSSC-001)

Coronavirus Clinical Trial

— CSSC-001  

Official title:

Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323800
• Other study ID #: IRB00245634
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2020
• Est. completion date: June 22, 2021

Study information

• Verified date: April 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 22, 2021
• Est. primary completion date: April 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Subjects must be 18 years of age or older

2. 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

1. Receipt of any blood product in past 120 days.

2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.

3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening.

4. Laboratory evidence of COVID-19 infection at time of screening.

5. History or known laboratory evidence of previous COVID-19 infection.

6. History of prior reactions to transfusion blood products.

7. Inability to complete therapy with the study product within 24 hours after randomization.

Related Conditions & MeSH terms

• Convalescence
• Coronavirus
• Coronavirus Infections

Intervention

Biological:
• Anti- SARS-CoV-2 Plasma
SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers = 1:320
• SARS-CoV-2 non-immune Plasma
Normal human plasma collected prior to December 2019

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	The Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Miami	Coral Gables	Florida
United States	Western Connecticut Health Network, Danbury Hospital	Danbury	Connecticut
United States	Wayne State University	Detroit	Michigan
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Center for American Indian Health - Gallup Office	Gallup	New Mexico
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of California, San Diego	La Jolla	California
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami Clinical Translational Research Site	Miami	Florida
United States	Western Connecticut Health Netowrk, Norwalk Hospital	Norwalk	Connecticut
United States	University of California, Irvine Health	Orange	California
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Lifespan/BrownUniversity (Rhode Island Hospital)	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	The University of Utah	Salt Lake City	Utah
United States	Center for American Indian Health - Shiprock Office	Shiprock	New Mexico
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Center for American Indian Health - Whiteriver Office	Whiteriver	Arizona
United States	University of Massachusetts Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection	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.	Day 28
Primary	Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"	Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.	Up to Day 28
Primary	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	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.	Up to Day 28
Secondary	Number of Participants With Severe Disease	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: Death; Requiring mechanical ventilation and/or in ICU; non-ICU hospitalization, requiring supplemental oxygen; non-ICU hospitalization, not requiring supplemental oxygen	Up to 28 days