Status:
TERMINATED
Convalescent Plasma vs. Standard Plasma for COVID-19
Lead Sponsor:
Stony Brook University
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 infectio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04344535
Start Date
April 8 2020
End Date
February 1 2021
Last Update
December 6 2021
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794