Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (CSSC-004)
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ClinicalTrials.gov Identifier: NCT04373460 |
Recruitment Status :
Completed
First Posted : May 4, 2020
Results First Posted : January 31, 2023
Last Update Posted : June 2, 2023
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Sponsor:
Johns Hopkins University
Collaborators:
State of Maryland
Bloomberg Foundation
United States Department of Defense
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Advancing Translational Sciences (NCATS)
Information provided by (Responsible Party):
Johns Hopkins University
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | April 30, 2020 | ||||||||||||||||
First Posted Date ICMJE | May 4, 2020 | ||||||||||||||||
Results First Submitted Date ICMJE | December 21, 2022 | ||||||||||||||||
Results First Posted Date ICMJE | January 31, 2023 | ||||||||||||||||
Last Update Posted Date | June 2, 2023 | ||||||||||||||||
Actual Study Start Date ICMJE | June 3, 2020 | ||||||||||||||||
Actual Primary Completion Date | January 14, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Serum SARS-CoV-2 Antibody Titers by Visit [ Time Frame: Days 0, 14, 28 and 90 ] Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Convalescent Plasma to Limit SARS-CoV-2 Associated Complications | ||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||
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. | ||||||||||||||||
Detailed Description | The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma. | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the <65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma. Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment |
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Condition ICMJE | SARS-CoV 2 | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 |
1225 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
1344 | ||||||||||||||||
Actual Study Completion Date ICMJE | December 14, 2022 | ||||||||||||||||
Actual Primary Completion Date | January 14, 2022 (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 | No | ||||||||||||||||
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 | NCT04373460 | ||||||||||||||||
Other Study ID Numbers ICMJE | IRB00247590 R01AI152078 ( U.S. NIH Grant/Contract ) W911QY2090012 ( Other Grant/Funding Number: Department of Defense ) U24TR001609 ( U.S. NIH Grant/Contract ) UL1TR003098 ( U.S. NIH Grant/Contract ) |
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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 | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||||||||||||
Verification Date | January 2023 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |