Study Objectives: Describe the prevalence and clinical manifestations of PASC in persons with confirmed SARS-CoV-2 (and comparator groups without history of SARS-CoV-2):
- In adults with vs. without HIV
- In children (regardless of HIV status)
- Establish a biobank to allow future evaluation of possible mechanisms and biomarkers of PASC
Study Design: This is an observational cohort study with follow-up over a total of ~24 months. Study visits will be comprised of two in-person visits (at enrollment and 3 months later) and 4 telephone interviews (at 1, 6, 12 and 24 months after enrollment)
Study Population and Size: This study is enrolling a cohort of approximately 700 adults ≥18 years of age who have laboratory-confirmed SARS-CoV-2: ~350 individuals living with HIV-1 and ~350 HIV-negative persons.
We will enroll an additional ~200 persons without known prior COVID diagnosis and whose point of care serologic SARS-CoV-2 test is negative.
This study is also enrolling a cohort of approximately 100 children <18 years of age who have laboratory-confirmed SARS-CoV-2; and ~100 children without known prior COVID diagnosis and whose point of care serologic SARS-CoV-2 test is negative, as a control group.
Study Duration: 2 years
Sponsor: The National Institutes of Health (NIH).