Convalescent Plasma to Stem Coronavirus (CSSC-001)
CSSC-001
1 other identifier
interventional
180
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
June 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2021
CompletedResults Posted
Study results publicly available
April 22, 2022
CompletedApril 26, 2022
April 1, 2022
11 months
March 24, 2020
April 20, 2022
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Number of Participants With Severe Disease
Up to 28 days
Study Arms (2)
High titer anti-SARS-CoV-2 plasma
EXPERIMENTALParticipants with High titer anti-SARS-CoV-2 plasma.
SARS-CoV-2 non-immune plasma
ACTIVE COMPARATORParticipants with SARS-CoV-2 non-immune plasma.
Interventions
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
Normal human plasma collected prior to December 2019
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, 85941, United States
University of California, San Diego
La Jolla, California, 92093, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, Irvine Health
Orange, California, 92868, United States
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, 06810, United States
Western Connecticut Health Netowrk, Norwalk Hospital
Norwalk, Connecticut, 06856, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Miami
Coral Gables, Florida, 33124, United States
University of Miami Clinical Translational Research Site
Miami, Florida, 33136, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01655, United States
Wayne State University
Detroit, Michigan, 48202, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Center for American Indian Health - Gallup Office
Gallup, New Mexico, 87301, United States
Center for American Indian Health - Shiprock Office
Shiprock, New Mexico, 87420, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
University of Rochester
Rochester, New York, 14642, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island, 02903, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (2)
Shoham S, Bloch EM, Casadevall A, Hanley D, Lau B, Gebo K, Cachay E, Kassaye SG, Paxton JH, Gerber J, Levine AC, Naeim A, 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 DJ. Transfusing Convalescent Plasma as Post-Exposure Prophylaxis Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Double-Blinded, Phase 2 Randomized, Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e477-e486. doi: 10.1093/cid/ciac372.
PMID: 35579509DERIVEDShoham 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 [Preprint]. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611.
PMID: 34931202DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shmuel Shoham
- Organization
- The Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Shmuel Shoham, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 27, 2020
Study Start
June 10, 2020
Primary Completion
April 22, 2021
Study Completion
June 22, 2021
Last Updated
April 26, 2022
Results First Posted
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
Sharing is governed by Johns Hopkins University Institutional Guidelines