Convalescent Plasma vs. Standard Plasma for COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04344535|
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2020
Last Update Posted : April 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID||Biological: Convalescent Plasma Biological: Standard Donor Plasma||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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.|
|Official Title:||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|
|Actual Study Start Date :||April 8, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||August 31, 2021|
|Active Comparator: Convalescent Donor Plasma||
Biological: Convalescent Plasma
450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
|Placebo Comparator: Standard Donor Plasma||
Biological: Standard Donor Plasma
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
- 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.
- 90 day all-cause mortality [ Time Frame: 90 days ]All cause mortality from randomization until 90 days post randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344535
|United States, New York|
|Stony Brook University Hospital|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Elliott Bennett-Guerrero, MD||Stony Brook Hospital|