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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

Tracking Information
First Submitted Date April 13, 2020
First Posted Date April 16, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date May 29, 2020
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A COVID-19 Symptom, Exposure and Immune Response Registry
Official Title COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults residing in the USA, regardless of past or current COVID-19 status
Condition COVID-19
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 13, 2020)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Parth Shah, MD (888) 928-1423 COVID19Study@obviohealth.com
Contact: Jalisa Watson, MHA (888) 928-1423 COVID19Study@obviohealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04348942
Other Study ID Numbers OBVIO-OBV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ObvioHealth
Study Sponsor ObvioHealth
Collaborators Not Provided
Investigators Not Provided
PRS Account ObvioHealth
Verification Date June 2020