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.
Study Type
OBSERVATIONAL
Enrollment
953
* blood, nasal swab, nasal wash, and saliva * optional stool swab
Response rate of SARS-CoV-2-specific B cells in peripheral blood samples
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Time frame: Measured through day 14
Magnitude of SARS-CoV-2-specific B cells in peripheral blood samples
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Time frame: Measured through day 14
Phenotypic characterization of SARS-CoV-2-specific B cells in peripheral blood samples
Characterized using fluorescently labeled recombinant proteins in combination with a flow cytometry phenotyping panel
Time frame: Measured through day 14
Response rate of SARS-CoV-2-specific antibody binding in serum samples
Measured by binding antibody multiplex assay (BAMA)
Time frame: Measured through day 28
Response rate of SARS-CoV-2-specific neutralizing antibodies in serum samples
Measured by neutralizing antibody assay (nAb)
Time frame: Measured through day 28
Magnitude of SARS-CoV-2-specific antibody binding antibodies in serum samples
Measured by binding antibody multiplex assay (BAMA)
Time frame: Measured through day 28
Magnitude of SARS-CoV-2-specific neutralizing antibodies in serum samples
Measured by neutralizing antibody assay (nAb)
Time frame: Measured through day 28
Response rate of SARS-CoV-2-specific binding antibodies in nasal wash samples
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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
...and 42 more locations
Measured by binding antibody multiplex assay (BAMA)
Time frame: Measured through day 28
Magnitude of SARS-CoV-2-specific binding antibodies in nasal wash samples
Measured by binding antibody multiplex assay (BAMA)
Time frame: Measured through day 28
Frequency of leukocyte populations in peripheral blood
Measured by flow cytometry
Time frame: Measured through day 14
Transcriptional profiles of peripheral blood leukocytes
Measured by gene expression analysis by RNA sequencing, real-time PCR, single-cell proteogenomic profiling
Time frame: Measured through day 14
Concentration of serum cytokines and other soluble factors
Measured by multiplexed protein detection assays and/or enzyme-linked immunosorbent assays (ELISA)
Time frame: Measured through day 28
Response rate of SARS-CoV-2-specific CD4+ and CD8+ T cells
Measured by flow cytometry
Time frame: Measured through day 28
Magnitude of SARS-CoV-2-specific CD4+ and CD8+ T cells
Measured by flow cytometry
Time frame: Measured through day 28
Functional profiling, including intracellular cytokine staining, of SARS-CoV-2-specific CD4+ and CD8+ T cells
Measured by flow cytometry
Time frame: Measured through day 28
Quantitation of viral RNA in nasal swabs
Measured by extraction of nucleic acid for analysis of microorganism RNA or DNA by qPCR and/or amplicon- or metagenomics-sequencing methods and subsequent gene and taxa-level bioinformatics analyses
Time frame: Measured through day 28