NCT04348942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 29, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2021

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

April 13, 2020

Last Update Submit

March 2, 2022

Conditions

Outcome Measures

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.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ObvioHealth

Orlando, Florida, 328017, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 16, 2020

Study Start

May 29, 2020

Primary Completion

March 21, 2021

Study Completion

March 21, 2021

Last Updated

March 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations