Status:
COMPLETED
Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief 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 tr...
Detailed Description
Emerging infectious diseases such as the Coronavirus disease 2019 (COVID-19) pandemic cause substantial morbidity and mortality. During the early emergent phases of such diseases, there is often no va...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ability of subject to understand, ask questions, and the willingness to sign the written informed consent document
- Age \>=18 years
- Ability to meet blood donor eligibility criteria as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards and DTM SOP, including:
- Weight \>=110 pounds (50 kg)
- Adequate peripheral venous access for plasma donation (as judged by the examiner)
- Vital signs (with exceptions as acceptable per DTM SOP)
- For COVID-19 convalescent subjects, the following criteria must be met:
- Prior diagnosis of COVID-19 documented by a laboratory test or by physician attestation
- Complete resolution of symptoms for at least 10 days prior to donation.
- Donors with residual loss of taste/smell are acceptable as long as they have no acute symptoms of COVID-19
- For vaccinated subjects, the following criteria must be met:
- -Subjects must meet FDA donor eligibility criteria to donate convalescent plasma
- Willingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high
- Willingness to have samples stored for clinical and/or genetic research testing
- EXCLUSION CRITERIA:
- Patients who cannot give proper informed consent due to inability to understand the nature of the proposed therapy and attendant risk
- Age under 18 years
- Females must not be pregnant (per routine blood donor criteria)
- Any sign of active infection, including but not limited to:
- Subjective or documented fever (\>37.5 (Infinite)C)
- Cough
- Shortness of breath
- Diarrhea
- Antibiotics within the prior 48 hours
- Considered immune suppressed for example current use of oral or parenteral steroids, highdose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs
- Permanent deferral from blood donation as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards, and DTM SOP
- Participation in medical research outside DTM that includes:
- -Protocols that are currently ongoing or will start during the duration of this study that require more than 500 mL of blood to be given in any 8-week period of time
- Total plasma protein level \< 6.0 g/dL
- Unwillingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high
- Unwillingness to have samples stored for clinical and/or genetic research testing
Exclusion
Key Trial Info
Start Date :
April 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT04360278
Start Date
April 21 2020
End Date
October 5 2022
Last Update
February 21 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892