A COVID-19 Symptom, Exposure and Immune Response Registry

Completed

• Conditions: COVID-19

• Registration Number: NCT04348942
• Lead Sponsor: ObvioHealth

Brief Summary

This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. Data collected will include participant medical histories, history of prior SARS-CoV-2 infection and exposure to known cases. On an ongoing basis data will be collected on new contacts with known cases, the presence of COVID-19 symptoms, including severity and outcome, and information on the immune system response to SARS-CoV-2 infection.

Detailed Description

This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. All data will be collected by participant entry into a mobile app designed for this study.

Upon entering the study, participants will be asked a series of questions about their prior exposure to the SARS-CoV-2 virus including reporting prior test results, and identification and description of contact with known or cases or other high risk encounters. Participants will also provide a detailed medical history.

On on ongoing basis, participants will be asked to report any symptoms associated with COVID-19 that they develop, and any new contacts they experience with known cases. Some participants will be sent an at-home SARS-CoV-2 antibody test and asked to report the results. In addition, participants will be asked to report the result of any other test they receive for COVID-19 outside of the study.

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2020-05-29
• Primary Completion: 2021-03-21
• Study Completion: 2021-03-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

• Open to any adult individuals (18 years of age or older) permanently residing in the United States
• Have regular access to smartphone and internet sufficient to support registry demands
• Willing and able to follow the procedures of the study
• Willing and able to provide informed consent

Exclusion Criteria

• Participants unable to understand the study protocol or provide informed consent
• Participants unable or unwilling to perform all requested study tasks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Registry Data	6 months	Compilation of registry data via regular self-reported questionnaires on symptoms (known to be associated with COVID-19 diagnosis including presence, severity, and duration using the Obvio-19 app.

Trial Locations

Locations (1)

ObvioHealth; 🇺🇸 Orlando, Florida, United States