Convalescent Plasma vs. Standard Plasma for COVID-19
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ClinicalTrials.gov Identifier: NCT04344535 |
Recruitment Status :
Terminated
(Insufficient eligible and consenting patients)
First Posted : April 14, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | April 10, 2020 | ||||
First Posted Date ICMJE | April 14, 2020 | ||||
Results First Submitted Date ICMJE | September 20, 2021 | ||||
Results First Posted Date ICMJE | December 6, 2021 | ||||
Last Update Posted Date | December 6, 2021 | ||||
Actual Study Start Date ICMJE | April 8, 2020 | ||||
Actual Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
28 Day Ventilator Free Days [ Time Frame: 28 days post randomization ] Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
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Original Primary Outcome Measures ICMJE |
28 day ventilator free days [ Time Frame: 28 days post randomization ] Number of days a patient is receiving mechanical invasive ventilation through 28 days post randomization. Patients who die during this time period are assigned 0 ventilator free days.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
90 Day All-cause Mortality [ Time Frame: 90 days ] All cause mortality from randomization until 90 days post randomization
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Original Secondary Outcome Measures ICMJE |
90 day all-cause mortality [ Time Frame: 90 days ] All cause mortality from randomization until 90 days post randomization
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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 vs. Standard Plasma for COVID-19 | ||||
Official Title ICMJE | Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection | ||||
Brief Summary | The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients. Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Staff in Transfusion Services (Blood Bank) at Stony Brook will be unblinded so they can collect, store, and dispense either convalescent plasma or standard plasma. They will affix an approved label with all required information, e.g. bar code, blood type, expiration date, and will indicate that the bag contains convalescent plasma/standard plasma. Primary Purpose: Treatment
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Condition ICMJE | COVID | ||||
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 | Terminated | ||||
Actual Enrollment ICMJE |
82 | ||||
Original Estimated Enrollment ICMJE |
500 | ||||
Actual Study Completion Date ICMJE | February 1, 2021 | ||||
Actual Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | There are 2 groups of research subjects: plasma donor and recipients Volunteer plasma donors can donate Convalescent Plasma if they:
Inclusion Criteria for Plasma Recipients:
Exclusion Criteria for Plasma Recipients:
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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 | NCT04344535 | ||||
Other Study ID Numbers ICMJE | SBU-COVID19-ConvalescentPlasma | ||||
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 | Elliott Bennett-Guerrero, Stony Brook University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Stony Brook University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Stony Brook University | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |