A COVID-19 Symptom, Exposure and Immune Response Registry

NCT ID: NCT04348942

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

804 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-29

Study Completion Date

2021-03-21

Brief Summary

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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

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ObvioHealth

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ObvioHealth

Orlando, Florida, United States

Site Status

Countries

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United States

References

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Shah P, Magee K, Buccellato KH, Ismond M, Watson J. Real world data on cardiometabolic diseases in U.S. adults during the SARS-CoV-2 pandemic: a decentralized registry study. Cardiovasc Diabetol. 2022 Feb 14;21(1):24. doi: 10.1186/s12933-022-01462-3.

Reference Type DERIVED
PMID: 35164745 (View on PubMed)

Other Identifiers

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OBVIO-OBV-001

Identifier Type: -

Identifier Source: org_study_id

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