Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
NCT04360278 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 258
Last updated 2024-02-21
Summary
Background:
The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA.
Objective:
To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease.
Eligibility:
Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19.
Design:
Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded.
Participants will donate plasma. It will be collected through whole blood donation or through apheresis.
For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn.
For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm.
Participants will have 3 to 20 plasma donations.
Participation will last up to 3 years.
Conditions
Sponsors & Collaborators
-
National Institutes of Health Clinical Center (CC)
lead NIH
Principal Investigators
-
Kamille A West-Mitchell, M.D. · National Institutes of Health Clinical Center (CC)
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-21
- Primary Completion
- 2022-10-05
- Completion
- 2022-10-05
Countries
- United States
Study Locations
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