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NCT04348942 Clinical Trial

A COVID-19 Symptom, Exposure and Immune Response Registry

COVID-19 Clinical Trial

Official title:
COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04348942
Other study ID # OBVIO-OBV-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 29, 2020
Est. completion date March 21, 2021

Study information
Verified date March 2022
Source ObvioHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 804
Est. completion date March 21, 2021
Est. primary completion date March 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States ObvioHealth Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
ObvioHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Registry Data 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. 6 months
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