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CompletedNCT04348942Updated Mar 4, 2022

A COVID-19 Symptom, Exposure and Immune Response Registry

An observational study in COVID-19, sponsored by ObvioHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by ObvioHealth · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
804
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 804 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with ObvioHealth as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults residing in the USA, regardless of past or current COVID-19 status

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

Exclusion Criteria:

  • Participants unable to understand the study protocol or provide informed consent
  • Participants unable or unwilling to perform all requested study tasks
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
804 participants (actual)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • ObvioHealth
    Orlando, Florida 328017, United States
08

References and documents

Publications

  • 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. PubMed 35164745 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04348942
Lead sponsor
ObvioHealth
Responsible party
Sponsor
First posted
Apr 16, 2020
Start date
May 29, 2020
Primary completion
Mar 21, 2021
Completion
Mar 21, 2021
Last update
Mar 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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