Status:
COMPLETED
Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
Lead Sponsor:
HIV Vaccine Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Conditions:
SARS-CoV-2
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name...
Detailed Description
This study aims to characterize the SARS-CoV-2-specific immunity in convalescent individuals. The observational cohort study will include 3 groups, as described in the table below. Participants will...
Eligibility Criteria
Inclusion
- Age 18 or older.
- Reports having had a positive test for SARS-CoV-2.
- Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment. Not excluded: individuals with symptoms consistent with residual sequelae of resolved COVID-19, in the clinical judgement of the investigator.
- Access to a participating HVTN or HPTN CRS and willingness to be followed for the planned duration of the study.
- Ability and willingness to provide informed consent.
- Assessment of understanding: volunteer demonstrates understanding of this study.
- Volunteers who were assigned female sex at birth: negative urine or serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 4 days of enrollment visit (ie, prior to enrollment blood draw or nasal collections). Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records) or having reached menopause (no menses for ≥ 1 year ), are not required to undergo pregnancy testing.
Exclusion
- Reports current COVID-19.
- Pregnant.
- Receipt of SARS-CoV-2 specific antibodies (eg, convalescent plasma or sera, monoclonal antibodies, hyperimmune globulin). Not excluded: antibody therapy without SARS-CoV-2 specificity (eg, IL-6 pathway inhibitors for COVID-19).
- SARS-CoV-2 vaccine(s) received in a prior vaccine trial.
- Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
759 Patients enrolled
Trial Details
Trial ID
NCT04403880
Start Date
May 13 2020
End Date
April 21 2022
Last Update
May 27 2022
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
3
Bridge HIV CRS
San Francisco, California, United States, 94143
4
George Washington University CRS
Washington D.C., District of Columbia, United States, 20037-1894