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Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)

Primary Purpose

Coronavirus, Convalescence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti- SARS-CoV-2 Plasma
SARS-CoV-2 non-immune Plasma
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Center for American Indian Health - Whiteriver Office
  • University of California, San Diego
  • University of California, Los Angeles
  • University of California, Irvine Health
  • Western Connecticut Health Network, Danbury Hospital
  • Western Connecticut Health Netowrk, Norwalk Hospital
  • MedStar Georgetown University Hospital
  • University of Miami
  • University of Miami Clinical Translational Research Site
  • NorthShore University HealthSystem
  • Anne Arundel Medical Center
  • The Johns Hopkins University
  • University of Massachusetts Worcester
  • Wayne State University
  • University of New Mexico Health Sciences Center
  • Center for American Indian Health - Gallup Office
  • Center for American Indian Health - Shiprock Office
  • Vassar Brothers Medical Center
  • University of Rochester
  • University of Cincinnati Medical Center
  • Lifespan/BrownUniversity (Rhode Island Hospital)
  • Baylor College of Medicine
  • University of Texas Health Science Center at Houston
  • The University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High titer anti-SARS-CoV-2 plasma

SARS-CoV-2 non-immune plasma

Arm Description

Participants with High titer anti-SARS-CoV-2 plasma.

Participants with SARS-CoV-2 non-immune plasma.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2020
Last Updated
April 22, 2022
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04323800
Brief Title
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
April 22, 2021 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Convalescence
Keywords
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1 ratio
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High titer anti-SARS-CoV-2 plasma
Arm Type
Experimental
Arm Description
Participants with High titer anti-SARS-CoV-2 plasma.
Arm Title
SARS-CoV-2 non-immune plasma
Arm Type
Active Comparator
Arm Description
Participants with SARS-CoV-2 non-immune plasma.
Intervention Type
Biological
Intervention Name(s)
Anti- SARS-CoV-2 Plasma
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 non-immune Plasma
Intervention Description
Normal human plasma collected prior to December 2019
Primary Outcome Measure Information:
Title
Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
Description
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.
Time Frame
Day 28
Title
Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events"
Description
Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
Time Frame
Up to Day 28
Title
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
Description
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.
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
Number of Participants With Severe Disease
Description
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
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Shoham, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Center for American Indian Health - Whiteriver Office
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Western Connecticut Health Network, Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Western Connecticut Health Netowrk, Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Facility Name
University of Miami Clinical Translational Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Center for American Indian Health - Gallup Office
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
Center for American Indian Health - Shiprock Office
City
Shiprock
State/Province
New Mexico
ZIP/Postal Code
87420
Country
United States
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Lifespan/BrownUniversity (Rhode Island Hospital)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Sharing is governed by Johns Hopkins University Institutional Guidelines
Citations:
PubMed Identifier
34931202
Citation
Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Currier J, Patel B, Allen ES, Anjan S, Appel L, Baksh S, Blair PW, Bowen A, Broderick P, Caputo CA, Cluzet V, Cordisco ME, Cruser D, Ehrhardt S, Forthal D, Fukuta Y, Gawad AL, Gniadek T, Hammel J, Huaman MA, Jabs DA, Jedlicka A, Karlen N, Klein S, Laeyendecker O, Lane K, McBee N, Meisenberg B, Merlo C, Mosnaim G, Park HS, Pekosz A, Petrini J, Rausch W, Shade DM, Shapiro JR, Singleton JR, Sutcliffe C, Thomas DL, Yarava A, Zand M, Zenilman JM, Tobian AAR, Sullivan D. Randomized controlled trial transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection. medRxiv. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611. Preprint.
Results Reference
derived

Learn more about this trial

Convalescent Plasma to Stem Coronavirus (CSSC-001)

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