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A Prospective Study of Acute Immune Responses to SARSCoV-2 Infection
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alabama CRS
Birmingham, Alabama, United States
Bridge HIV CRS
San Francisco, California, United States
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Miami, Florida, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Columbia P&S CRS
New York, New York, United States
Start Date
July 20, 2020
Primary Completion Date
June 2, 2022
Completion Date
June 2, 2022
Last Updated
July 26, 2022
953
ACTUAL participants
Sample collection
OTHER
Lead Sponsor
COVID-19 Prevention Network
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287