NCT04431414

A Study of Immune Responses to the Virus That Causes COVID-19

A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 953 (actual)
• Sponsor: COVID-19 Prevention Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn more about the acute response to 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 can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

Detailed description

This is a prospective study of acute immune responses to SARSCoV-2 infection. The study will include 3 groups, as described in the table below. Groups are defined based on clinical status at enrollment, but for the purposes of data analysis, participants who experience disease progression can contribute data to other cohorts. Participants will complete six visits over 28 days followed by a health contact at Month 2 (one month after the last scheduled visit). 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 review of medical history; interviews/questionnaires; pregnancy tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash, and saliva sample collection; and optional stool sample collection.

Conditions

• SARS-CoV-2
• COVID-19

Interventions

Type	Name	Description
OTHER	Sample collection	* blood, nasal swab, nasal wash, and saliva * optional stool swab

Timeline

• Start date: 2020-07-20
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2020-06-16
• Last updated: 2022-07-26

Locations

52 sites across 11 countries: United States, Argentina, Botswana, Brazil, Malawi, Mexico, Peru, South Africa, Tanzania, Zambia, Zimbabwe