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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04348942|
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : March 4, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
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]|
|Actual Enrollment :||804 participants|
|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|
|Actual Primary Completion Date :||March 21, 2021|
|Actual Study Completion Date :||March 21, 2021|
- 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.
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.
|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|
- 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
- Participants unable to understand the study protocol or provide informed consent
- Participants unable or unwilling to perform all requested study tasks
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
|United States, Florida|
|Orlando, Florida, United States, 328017|
|Other Study ID Numbers:||
|First Posted:||April 16, 2020 Key Record Dates|
|Last Update Posted:||March 4, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases