NCT04403880

Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19

Characterizing SARS-CoV-2-specific Immunity in Convalescent Individuals

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 760 (actual)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 "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.

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 complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR 2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits approximately 2 months, 4 months, and 1 year later. Participants diagnosed with SARS-CoV-2 infection at an optional follow-up visit may be contacted more frequently. Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19. Study visits may include physical examinations, medical history, questionnaires, pregnancy tests (for participants assigned female at birth), blood draws, optional nasal samples, and optional HIV testing.

Conditions

• SARS-CoV-2
• COVID-19

Interventions

Type	Name	Description
OTHER	Sample collection	* Optional nasal specimen(s) * Blood collection

Timeline

• Start date: 2020-05-13
• Primary completion: 2022-04-21
• Completion: 2022-04-21
• First posted: 2020-05-27
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

53 sites across 6 countries: United States, Malawi, Peru, South Africa, Zambia, Zimbabwe