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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
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

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.


Condition or disease Intervention/treatment Phase
COVID Biological: Convalescent Plasma Biological: Standard Donor Plasma Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 90 day all-cause mortality [ Time Frame: 90 days ]
    All cause mortality from randomization until 90 days post randomization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

There are 2 groups of research subjects: plasma donor and recipients

Volunteer plasma donors can donate Convalescent Plasma if they:

  • have adequate antibody levels against COVID-19 per FDA Guidelines
  • have had no symptoms of COVID-19 for at least 14 days
  • meet routine plasma donation criteria

Inclusion Criteria for Plasma Recipients:

  • Adults 18 years of age or older
  • Hospitalized with PCR+ COVID-19 infection
  • If female must not be pregnant and/or breastfeeding.

Exclusion Criteria for Plasma Recipients:

  • Unable to randomize patient within 14 days of admission to Stony Brook Hospital (or any other hospital if a transfer to Stony Brook Hospital).
  • In the treating physician's opinion, the patient cannot tolerate a 450-550 mL infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic
  • Contraindication to transfusion or history of prior reactions to blood transfusions

Information from the National Library of Medicine

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


Locations
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United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Elliott Bennett-Guerrero, MD Stony Brook Hospital
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Responsible Party: Elliott Bennett-Guerrero, Professor of Anesthesiology, Stony Brook University
ClinicalTrials.gov Identifier: NCT04344535    
Other Study ID Numbers: SBU-COVID19-ConvalescentPlasma
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No