COVID-19NCT04348942
A COVID-19 Symptom, Exposure and Immune Response Registry
An observational study of COVID-19, run by ObvioHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 804 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 21 Mar 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults residing in the USA, regardless of past or current COVID-19 status
Who may be able to join
- 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
Who cannot join
- Participants unable to understand the study protocol or provide informed consent
- Participants unable or unwilling to perform all requested study tasks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population
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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start29 May 2020
- Primary completion21 Mar 2021
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 804 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- ObvioHealth
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348942
- Sponsor's protocol ID
- OBVIO-OBV-001
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Study - A Primarily Prospective Observational Study of COVID-19 Clinical Characteristics and Acquired Immune Response Within the General Population
- ClinicalTrials.gov ID
- NCT04348942
- Acronym / sponsor ID
- OBVIO-OBV-001
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- ObvioHealthIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults residing in the USA, regardless of past or current COVID-19 status
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participants unable to understand the study protocol or provide informed consent
- Participants unable or unwilling to perform all requested study tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 35164745Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by ObvioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry Data (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.