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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 : Terminated (Insufficient eligible and consenting patients)
First Posted : April 14, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Elliott Bennett-Guerrero, Stony Brook University

Tracking Information
First Submitted Date  ICMJE April 10, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date May 4, 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
 (submitted: April 13, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
90 Day All-cause Mortality [ Time Frame: 90 days ]
All cause mortality from randomization until 90 days post randomization
Original Secondary Outcome Measures  ICMJE Same as current
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
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
Condition  ICMJE COVID
Intervention  ICMJE
  • 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.
  • Biological: Standard Donor Plasma
    450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Study Arms  ICMJE
  • Active Comparator: Convalescent Donor Plasma
    Intervention: Biological: Convalescent Plasma
  • Placebo Comparator: Standard Donor Plasma
    Intervention: Biological: Standard Donor Plasma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 29, 2021)
82
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elliott Bennett-Guerrero, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elliott Bennett-Guerrero, MD Stony Brook Hospital
PRS Account Stony Brook University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP