dbGaP Study Accession: phs003360

NIH Institute/Center: NIBIB

RADx Data Program: RADx Tech

Release Date: 04/17/2024

DOI: 10.60773/jrhz-2h83

Study Description: The COVID Detect/COVID-19 viral dynamics study was planned and performed to assess SARS-CoV-2 viral dynamics in early infection, accuracy/persistence of SARS-CoV-2 antigen/PCR testing, clinical aspects of mild COVID-19, and potential SARS-CoV-2 transmission dynamics or risk factors. This study included a cohort of adult students and employees of University of Illinois Urbana-Champaign (UIUC) and Northwestern University who tested positive for SARS-CoV-2 as part of campus surveillance programs (isolation participants) or close contacts (particularly roommates) of individuals testing positive for SARS-CoV-2 (quarantine participants). Isolation participants were enrolled within 24 hours of positive testing and quarantine participants were enrolled within 5 days of last known exposure. All participants were required to have negative campus surveillance testing within 7 days of enrollment. Isolation participants completed daily surveys and collected observed nasal swabs and saliva (UIUC only) for 14 days. Quarantine participants completed daily surveys and collected samples for 7 days if SARS-CoV-2 RT-PCR remained negative; if converted positive by SARS-CoV-2 PCR, they collected daily samples for full 14 days. Each day of sample collection were analyzed as follows: nasal swab for SARS-CoV-2 POC Quidel antigen, nasal swab into VTM for SARS-CoV-2 Roche RT-PCR, saliva for SARS-CoV-2 PCR (UIUC only), and nasal swab into VTM for storage and subsequent whole genome virus sequencing and viral culture assay.

Updated Date: 04/17/2024

Principal Investigator: Mcmanus, David

Has Data Files: Yes

Study Domain: Rapid Diagnostic Test (RDT)

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Antigen Testing Device; Smartphone; Survey

Keywords: COVID Transmission Dynamics; Early Infection; COVID Risk Factors; Congregate Settings; Viral Dynamics; People Living in Congregate Settings; COVID-positive Patients; People with Known COVID Exposure

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: University of Illinois Urbana-Champaign and Northwestern University

Data Types: Clinical; Questionnaires/Surveys; Other

Data Types, Other: SARS-CoV-2 virus testing/assays -- point-of-care (POC) antigen, reverse transcription polymerase chain reaction (RT-PCR), and viral culture

Study Start Date: 12/02/2020

Study End Date: 06/02/2021

Species: Human Data

Estimated Cohort Size: 300

Study Population Focus: Adults; Older Adults or Elderly

Acknowledgement Statement: This study was supported through funding, 3U54HL143541-05S1, for the National Institute of Biomedical Imaging and Bioengineering (NIBIB) as part of the RADx Tech program. This work was also supported by the National Institute of Biomedical Imaging and Bioengineering through the Center for Innovation in Point of Care Technologies for HIV/AIDS at Northwestern (C-THAN) [3U54EB027049-02S1]. Approved users should acknowledge the provision of data access by dbGaP for accession phs003360.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-272

NIH Grant or Contract Number(s): 3U54HL143541-05S1

Consent/Data Use Limitations: General Research Use; Disease-Specific for COVID-19