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A COVID-19 Symptom, Exposure and Immune Response Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348942
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
COVID-19

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021



Primary Outcome Measures :
  1. Registry Data [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348942


Contacts
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Contact: Parth Shah, MD (888) 928-1423 COVID19Study@obviohealth.com
Contact: Jalisa Watson, MHA (888) 928-1423 COVID19Study@obviohealth.com

Locations
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United States, Florida
ObvioHealth Recruiting
Orlando, Florida, United States, 328017
Contact: Parth Shah, MD    888-928-1423    COVID19Study@obviohealth.com   
Contact: Jalisa Watson, MHA    888 928 1423    COVID19Study@obviohealth.com   
Sponsors and Collaborators
ObvioHealth
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Responsible Party: ObvioHealth
ClinicalTrials.gov Identifier: NCT04348942    
Other Study ID Numbers: OBVIO-OBV-001
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No