Status:
COMPLETED
Collection of Anti-SARS-CoV-2 Immune Plasma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18-70 years
Brief Summary
Background: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There ...
Detailed Description
Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and causes substantial morbidity and morta...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Provide written informed consent before initiation of any study procedures.
- Age greater than or equal to 18 years old and less than or equal to 70 years old.
- Subjects must not be symptomatic, must be afebrile for ≥14 days, beyond 28 days of the resolution of their acute COVID-19 illness, and must enroll within 18 months of onset of illness, and must meet at least 1 of the following:
- History suggestive of resolved COVID-19-like illness (e.g., prior fever, dry cough, and shortness of breath). OR
- History of positive test for SARS-CoV-2 (either serologic or RT-PCR) OR
- Documented anti-SARSCoV-2 neutralizing antibody titer of at least 1:80
- Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
- Females must have a negative anti-HLA screening test
- Weight greater than or equal to110 pounds (50 kg)
- Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma donation
- Adequate peripheral venous access for plasma donation (as judged by the examiner)
- Willingness to have samples stored
- EXCLUSION CRITERIA:
- Any sign of active illness of any kind including COVID-19 illness (as judged by the investigator), including but not limited to:
- Subjective or documented fever (greater than or equal to 38°C)
- Dry cough
- Shortness of breath
- Participation in medical research that includes:
- Protocols that are currently ongoing or will start during the duration of this study that require more than 100 mL of blood to be given in any 8-week period of time
- Administration of any unlicensed drug within the last 1 month or during the duration of this study, per investigation discretion
- Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04344977
Start Date
June 1 2020
End Date
March 3 2021
Last Update
March 5 2021
Active Locations (3)
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1
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States, 90502
2
University of Miami Infectious Diseases Research Unit
Miami, Florida, United States, 33136
3
Bloodworks Northwest
Seattle, Washington, United States, 98104