Convalescent Plasma vs. Standard Plasma for COVID-19
Primary Purpose
COVID
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Convalescent Plasma
Standard Donor Plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility 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
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Convalescent Donor Plasma
Standard Donor Plasma
Arm Description
Outcomes
Primary Outcome Measures
28 Day Ventilator Free Days
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
90 Day All-cause Mortality
All cause mortality from randomization until 90 days post randomization
Full Information
NCT ID
NCT04344535
First Posted
April 10, 2020
Last Updated
December 2, 2021
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT04344535
Brief Title
Convalescent Plasma vs. Standard Plasma for COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient eligible and consenting patients
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Convalescent Donor Plasma
Arm Type
Active Comparator
Arm Title
Standard Donor Plasma
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Standard Donor Plasma
Intervention Description
450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
Primary Outcome Measure Information:
Title
28 Day Ventilator Free Days
Description
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.
Time Frame
28 days post randomization
Secondary Outcome Measure Information:
Title
90 Day All-cause Mortality
Description
All cause mortality from randomization until 90 days post randomization
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Bennett-Guerrero, MD
Organizational Affiliation
Stony Brook Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived
PubMed Identifier
33870923
Citation
Bennett-Guerrero E, Romeiser JL, Talbot LR, Ahmed T, Mamone LJ, Singh SM, Hearing JC, Salman H, Holiprosad DD, Freedenberg AT, Carter JA, Browne NJ, Cosgrove ME, Shevik ME, Generale LM, Andrew MA, Nachman S, Fries BC; Stony Brook Medicine COVID Plasma Trial Group; Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators; Principal Investigator, Critical Care; Pathology/Blood Bank; Infectious Disease; Safety Monitor; Biostatistics; Hematology; (Blood Bank; and; Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling); Team Leader; and; Team 2 (In Person Screening Visits); Team Leader; and; Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture); Team Leader; and; and; and; and; Team M (Antibody Testing/Randomization):; Team Leader; and; Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support); (IND support); (IRB support), and; Data and Safety Monitoring Board (DSMB); and; (Chair) and; (unblinded DSMB statistician); Stony Brook Medicine COVID Plasma Trial Group and Stony Brook Medicine COVID Plasma Trial Group are as follows: Investigators and Principal Investigator, Critical Care and Pathology/Blood Bank and Infectious Disease and Safety Monitor and Biostatistics and Hematology and (Blood Bank and and and Pathology, Laboratory Services). Team 1 (Online Survey/In Person Scheduling) and Team Leader and and and Team 2 (In Person Screening Visits) and Team Leader and and and Team 3 (Patient/Recipient Screening, Plasma Administration, Data Capture) and Team Leader and and and and and and and and and Team M (Antibody Testing/Randomization): and Team Leader and and and Plaque Reduction Neutralization Assay: Janet Hearing. Regulatory (Investigational New Drug [IND] and Institutional Review Board [IRB] support) and (IND support) and (IRB support), and and Data and Safety Monitoring Board (DSMB) and and and (Chair) and and (unblinded DSMB statistician). Severe Acute Respiratory Syndrome Coronavirus 2 Convalescent Plasma Versus Standard Plasma in Coronavirus Disease 2019 Infected Hospitalized Patients in New York: A Double-Blind Randomized Trial. Crit Care Med. 2021 Jul 1;49(7):1015-1025. doi: 10.1097/CCM.0000000000005066.
Results Reference
derived
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Convalescent Plasma vs. Standard Plasma for COVID-19
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