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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663776
• Other study ID #: P00036213
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: December 8, 2021

Study information

• Verified date: March 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Tract Infection
• Communicable Diseases
• Covid19
• Infections
• Influenza
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Google LLC.

Country where clinical trial is conducted

United States, 

References & Publications (17)

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Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of in?uenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.	The de?nition 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 ?nal outcome, the total incidence may not add up to exactly 100%.	6-month participation period
Primary	Incidence of COVID-like illness (CLI) in a study participant.	CLI will be de?ned as fever and cough, or shortness of breath, or loss of smell. Incidence will be de?ned 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 ?nal outcome, the total incidence may not add up to exactly 100%.	6-month participation period
Secondary	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 ?nal outcome, the total prevalence may not add up to exactly 100%.	1-year study period