dbGaP Study Accession: phs003027

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

DOI: 10.60773/cghr-4117

Release Date: 08/29/2022

Updated Date: 04/17/2024

Study Description: This biorepository was established to obtain, store, and share body fluid samples for SARS-CoV-2 research. Samples were obtained at the study sites. The overall study duration was open ended to allow ongoing enrollment and indefinite storage of samples. There was no limit to the number of volunteers who could consent to participate in the study. The time frame for enrollment of volunteers and endpoints of the study were open ended, and duration of participation was only limited by withdrawal of consent to store data or samples. Participants were asked to complete a survey through the Eureka digital study platform. The survey collected demographic information, delineated the types of samples provided, and collected information about experience with COVID-19 (e.g., symptoms or exposures). Samples were collected in a location equipped for safely obtaining specimens from potentially SARS-CoV-2-infected participants, e.g., ED or inpatient units, ambulatory clinics, or COVID-19 community screening events.

Principal Investigator: Broach, John

Has Data Files: Yes

Study Domain: Virological Testing

Data Collection Method: Survey; Smartphone

Keywords: Near Patient Testing

Study Design: Open Cohort

Multi-Center Study: Yes

Study Sites: UMass Chan Medical School; UMass Lowell; Oregon Health & Science University; Northwestern University; University of Iowa; University of Kansas Medical Center; Morehouse School of Medicine; John Hopkins University;

Data Types: Behavioral; Questionnaires/Surveys

Study Start Date: 05/21/2021

Study End Date: 03/31/2022

Species: Human Data

Estimated Cohort Size: 1721

Study Population Focus: Children; Older Adults or Elderly; Adults

Acknowledgement Statement: This study was supported through funding, 5U54HL143541-05, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx Tech program. National Institutes of Health (NIH) program support came from NHLBI (Erin Iturriaga and Jue Chen), NIBIB (Bill Heetderks and Andrew Weitz), and NIH Presidential Innovation Fellow Krishna Juluru. Operations support and data management occurred primarily through the UMass Chan Medical School’s Center for Clinical and Translational Science, Clinical Studies Core, and the Department of Population and Quantitative Health Sciences. Additional recruitment of participants occurred at UMass Lowell; Oregon Health & Science University; Northwestern University; University of Iowa; University of Kansas Medical Center; Morehouse School of Medicine; John Hopkins University. Data collection occurred through the Eureka Platform managed by the UCSF team. Quest Diagnostics ran the standard comparators (Roche 6800 Cobas PCR for SARS-CoV-2 assays). Approved users should acknowledge the provision of data access by dbGaP for accession phs003027.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: PAR-17-453

NIH Grant or Contract Number(s): 5U54HL143541-05

Consent/Data Use Limitations: General Research Use