Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)
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ClinicalTrials.gov Identifier: NCT04323800 |
Recruitment Status :
Completed
First Posted : March 27, 2020
Results First Posted : April 22, 2022
Last Update Posted : April 26, 2022
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 24, 2020 | ||||||
First Posted Date ICMJE | March 27, 2020 | ||||||
Results First Submitted Date ICMJE | April 20, 2022 | ||||||
Results First Posted Date ICMJE | April 22, 2022 | ||||||
Last Update Posted Date | April 26, 2022 | ||||||
Actual Study Start Date ICMJE | June 10, 2020 | ||||||
Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Cumulative incidence of composite outcome of disease severity [ Time Frame: Day 28 ] The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Number of Participants With Severe Disease [ Time Frame: Up to 28 days ] 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:
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Convalescent Plasma to Stem Coronavirus (CSSC-001) | ||||||
Official Title ICMJE | 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 | ||||||
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). | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 1:1 ratio Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. pii: 2021.12.13.21267611. doi: 10.1101/2021.12.13.21267611. Update in: Clin Infect Dis. 2022 May 17;:. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
180 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Actual Study Completion Date ICMJE | June 22, 2021 | ||||||
Actual Primary Completion Date | April 22, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04323800 | ||||||
Other Study ID Numbers ICMJE | IRB00245634 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Johns Hopkins University | ||||||
Original Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||||
Original Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||
Verification Date | April 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |