Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

Study Overview
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Brief Summary
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This is a prospective observational study using a mobile study platform (app) that is designed for use on Android phones. Study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. Participants will also report use of prevention techniques on the weekly survey. Mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. The overall goals of the study are to track spread of coronavirus-like illness (CLI), inﬂuenza-like illness (ILI) and non-speciﬁc respiratory illness (NSRI) on a near-real time basis and identify speciﬁc behaviors associated with an increased or decreased risk of developing these conditions.

Official Title
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Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

Conditions
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Covid19, Influenza, Respiratory Tract Infections, Acute Respiratory Tract Infection, Acute Respiratory Distress Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18 years or older, Android mobile phone user, Resides in the United States (has a US home address) Exclusion Criteria: Under the age of 18, Does not use an Android mobile device, Opts out of sharing mobility data, Does not live within the United States

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inﬂuenza-like illness (ILI) and COVID-like illness (CLI) in a study participant. | The deﬁnition of ILI will be adapted from CDC guidelines as a participant reporting fever in addition to cough or sore throat without any other known cause. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the ﬁnal outcome, the total incidence may not add up to exactly 100%. | 6-month participation period | 
| Incidence of COVID-like illness (CLI) in a study participant. | CLI will be deﬁned as fever and cough, or shortness of breath, or loss of smell. Incidence will be deﬁned as reporting of the above symptoms in the 7 days prior (and not previously). All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the ﬁnal outcome, the total incidence may not add up to exactly 100%. | 6-month participation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Prevalence | Patterns of mobility (e.g. time away from home, use of public transportation), and reported use of prevention strategies such as wearing a mask and social distancing in participants who do, or don't, develop CIL and/or ILI will be compared. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the ﬁnal outcome, the total prevalence may not add up to exactly 100%. | 1-year study period |