Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT04344535
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04344535
Study Brief:
Protocol Section:
NCT04344535