Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
CSSC-004
Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19
5 other identifiers
interventional
1,225
1 country
29
Brief Summary
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
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
29 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
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
June 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2022
CompletedResults Posted
Study results publicly available
January 31, 2023
CompletedJune 2, 2023
January 1, 2023
1.6 years
April 30, 2020
December 21, 2022
May 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Up to day 28
Cumulative Incidence of Severe Infusion Reactions
Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Up to day 28
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events
Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Up to day 90
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)
Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.
Up to day 28
Secondary Outcomes (1)
Serum SARS-CoV-2 Antibody Titers by Visit
Days 0, 14, 28 and 90
Other Outcomes (8)
Number of Participants With ICU Admission
Up to day 90
Number of Participants With Invasive Mechanical Ventilation
Up to day 90
Number of Participants Who Died
Up to day 90
- +5 more other outcomes
Study Arms (2)
SARS-CoV-2 convalescent plasma
EXPERIMENTALSARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Standard Control plasma
ACTIVE COMPARATORPlasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Interventions
SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Competent and capable to provide informed consent
- Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab
- Experiencing any symptoms of COVID-19 including but not limited to fever(T\> 100.5º F), cough, or other COVID associated symptoms like anosmia
- ≤ 8 days since the first symptoms of COVID-19
- ≤ 8 days since first positive SARS-CoV-2 RNA test
- Able and willing to comply with protocol requirements listed in the informed consent
You may not qualify if:
- Hospitalized or expected to be hospitalized within 24 hours of enrollment
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance
- History of prior reactions to transfusion blood products
- Inability to complete therapy with the study product within 24 hours after enrollment
- Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- State of Marylandcollaborator
- Bloomberg Philanthropiescollaborator
- United States Department of Defensecollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- National Center for Advancing Translational Sciences (NCATS)collaborator
Study Sites (29)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Center for American Indian Health - Chinle Office
Chinle, Arizona, 86503, United States
Mayo Clinic, Phoenix
Phoenix, Arizona, 85054, United States
University of Arizona, Phoenix
Tucson, Arizona, 85719, United States
University of Arizona, Tuscon
Tucson, Arizona, 85724, United States
Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, 85941, 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 Network, Norwalk Hospital
Norwalk, Connecticut, 06856, 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
Tulane University
New Orleans, Louisiana, 70112, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
MedStar Washington Hospital Center
Hyattsville, Maryland, 20782, 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 (5)
Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv [Preprint]. 2021 Dec 21:2021.12.10.21267485. doi: 10.1101/2021.12.10.21267485.
PMID: 34981068RESULTPark HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. JCI Insight. 2024 Mar 14;9(8):e178460. doi: 10.1172/jci.insight.178460.
PMID: 38483534DERIVEDPark HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AAR, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. medRxiv [Preprint]. 2023 Dec 15:2023.04.13.23288353. doi: 10.1101/2023.04.13.23288353.
PMID: 37131659DERIVEDBaksh SN, Heath SL, Fukuta Y, Shade D, Meisenberg B, Bloch EM, Tobian AAR, Spivak ES, Patel B, Gerber J, Raval JS, Forthal D, Paxton J, Mosnaim G, Anjan S, Blair J, Cachay E, Currier J, Das P, Huaman M, Sutcliffe C, Yarava A, Casadevall A, Sullivan D, Hanley D, Gebo KA. Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial. J Infect Dis. 2023 May 29;227(11):1266-1273. doi: 10.1093/infdis/jiad023.
PMID: 36722044DERIVEDSullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.
PMID: 35353960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David J. Sullivan
- Organization
- Johns Hopkins University Bloomberg School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
David J Sullivan, MD
The 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
April 30, 2020
First Posted
May 4, 2020
Study Start
June 3, 2020
Primary Completion
January 14, 2022
Study Completion
December 14, 2022
Last Updated
June 2, 2023
Results First Posted
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After publication of initial study manuscript
- Access Criteria
- Public
Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.