Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- HIV Vaccine Trials Network
- Study ID
- NCT04403880
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Sample collection — OTHER* Optional nasal specimen(s) * Blood collection
Study Details
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 "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.
Key Dates
- Start date
- May 13, 2020
- Status verified
- Dec 2025
- Primary completion
- Apr 21, 2022
- Completion
- Apr 21, 2022
Study Design
- Enrollment
- 760 participants (actual)
Arms
- Arm: Group 1Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 1A: Persons with asymptomatic infection, ages 18 through 55, inclusive * 1B: Persons with asymptomatic infection, age \> 55 * 1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55 * 1D: Persons with symptomatic infection (ie, COVID-19), age \> 55
- Arm: Group 2Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3 * 2A: Persons 18 through 55 years of age * 2B: Persons \> 55 years of age
- Arm: Group 3Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)
Primary Outcome Measure
SARS-CoV-2-specific Antibody Binding Response Rate (BAMA IgG1) by Region and Enrollment Group Among America Cohort [ Time Frame: Measured at Months 0, 2, 4 ]
Locations (21)
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