Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2020-06-10
2021-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High titer anti-SARS-CoV-2 plasma
Participants with High titer anti-SARS-CoV-2 plasma.
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
Participants with SARS-CoV-2 non-immune plasma.
SARS-CoV-2 non-immune Plasma
Normal human plasma collected prior to December 2019
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Shmuel Shoham, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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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 D.C., District of Columbia, United States
University of Miami
Coral Gables, Florida, United States
University of Miami Clinical Translational Research Site
Miami, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
The Johns Hopkins University
Baltimore, Maryland, United States
University of Massachusetts Worcester
Worcester, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Center for American Indian Health - Gallup Office
Gallup, New Mexico, United States
Center for American Indian Health - Shiprock Office
Shiprock, New Mexico, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
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 [Preprint]. 2021 Dec 14:2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00245634
Identifier Type: -
Identifier Source: org_study_id
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