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: Not yet recruiting

Administrative data

• NCT number: NCT04525118
• Other study ID #: IRB-P00036213
• Status: Not yet recruiting
• Start date: September 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: Boston Children's Hospital
• Contact: Kara Sewalk, MPH
• Phone: 857-218-5188
• Email: kara.sewalk[@]childrens.harvard.edu
• 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: Not yet recruiting
• Enrollment: 100000
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult 18 years old or older

• Android mobile phone user

• Resides with 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 Respiratory Infection
• Communicable Diseases
• Covid19
• Infection
• Influenza
• Influenza -Like Illness
• Influenza, Human
• Respiratory Tract Infections

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Google Inc.

References & Publications (17)

Bajardi P, Vespignani A, Funk S, Eames KT, Edmunds WJ, Turbelin C, Debin M, Colizza V, Smallenburg R, Koppeschaar CE, Franco AO, Faustino V, Carnahan A, Rehn M, Paolotti D. Determinants of follow-up participation in the Internet-based European influenza surveillance platform Influenzanet. J Med Internet Res. 2014 Mar 10;16(3):e78. doi: 10.2196/jmir.3010. — View Citation

Baltrusaitis K, Brownstein JS, Scarpino SV, Bakota E, Crawley AW, Conidi G, Gunn J, Gray J, Zink A, Santillana M. Comparison of crowd-sourced, electronic health records based, and traditional health-care based influenza-tracking systems at multiple spatial resolutions in the United States of America. BMC Infect Dis. 2018 Aug 15;18(1):403. doi: 10.1186/s12879-018-3322-3. — View Citation

Garg S, Kim L, Whitaker M, O'Halloran A, Cummings C, Holstein R, Prill M, Chai SJ, Kirley PD, Alden NB, Kawasaki B, Yousey-Hindes K, Niccolai L, Anderson EJ, Openo KP, Weigel A, Monroe ML, Ryan P, Henderson J, Kim S, Como-Sabetti K, Lynfield R, Sosin D, Torres S, Muse A, Bennett NM, Billing L, Sutton M, West N, Schaffner W, Talbot HK, Aquino C, George A, Budd A, Brammer L, Langley G, Hall AJ, Fry A. Hospitalization Rates and Characteristics of Patients Hospitalized with Laboratory-Confirmed Coronavirus Disease 2019 - COVID-NET, 14 States, March 1-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464. doi: 10.15585/mmwr.mm6915e3. — View Citation

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. — View Citation

Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Nair S, Jones MA, Thorning S, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD006207. doi: 10.1002/14651858.CD006207.pub4. Review. — View Citation

Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1. — View Citation

Mateus AL, Otete HE, Beck CR, Dolan GP, Nguyen-Van-Tam JS. Effectiveness of travel restrictions in the rapid containment of human influenza: a systematic review. Bull World Health Organ. 2014 Dec 1;92(12):868-880D. doi: 10.2471/BLT.14.135590. Epub 2014 Sep 29. Review. — View Citation

Menni C, Valdes AM, Freidin MB, Sudre CH, Nguyen LH, Drew DA, Ganesh S, Varsavsky T, Cardoso MJ, El-Sayed Moustafa JS, Visconti A, Hysi P, Bowyer RCE, Mangino M, Falchi M, Wolf J, Ourselin S, Chan AT, Steves CJ, Spector TD. Real-time tracking of self-reported symptoms to predict potential COVID-19. Nat Med. 2020 Jul;26(7):1037-1040. doi: 10.1038/s41591-020-0916-2. Epub 2020 May 11. — View Citation

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Schuchat A; CDC COVID-19 Response Team. Public Health Response to the Initiation and Spread of Pandemic COVID-19 in the United States, February 24-April 21, 2020. MMWR Morb Mortal Wkly Rep. 2020 May 8;69(18):551-556. doi: 10.15585/mmwr.mm6918e2. — View Citation

Smolinski MS, Crawley AW, Baltrusaitis K, Chunara R, Olsen JM, Wójcik O, Santillana M, Nguyen A, Brownstein JS. Flu Near You: Crowdsourced Symptom Reporting Spanning 2 Influenza Seasons. Am J Public Health. 2015 Oct;105(10):2124-30. doi: 10.2105/AJPH.2015.302696. Epub 2015 Aug 13. — View Citation

Thompson WW, Weintraub E, Dhankhar P, Cheng PY, Brammer L, Meltzer MI, Bresee JS, Shay DK. Estimates of US influenza-associated deaths made using four different methods. Influenza Other Respir Viruses. 2009 Jan;3(1):37-49. doi: 10.1111/j.1750-2659.2009.00073.x. — View Citation

Tong JY, Wong A, Zhu D, Fastenberg JH, Tham T. The Prevalence of Olfactory and Gustatory Dysfunction in COVID-19 Patients: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2020 Jul;163(1):3-11. doi: 10.1177/0194599820926473. Epub 2020 May 5. — View Citation

Wójcik OP, Brownstein JS, Chunara R, Johansson MA. Public health for the people: participatory infectious disease surveillance in the digital age. Emerg Themes Epidemiol. 2014 Jun 20;11:7. doi: 10.1186/1742-7622-11-7. eCollection 2014. Review. — 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 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
Primary	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	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

External Links

•   Arafat R, Bakota E, Santos E. Estimating FluNearYou correlation to CDC'sILINe. Int J Infect Dis 2016;53S:163.
•   Bonawitz K, Ivanov V, Kreuter B, et al. Practical secure aggregation for privacy-preserving machine learning. CCS '17; 2017; Dallas, TX. p. 1175-91.
•   CDC. COVIDView. A weekly surveillance summary of US COVID-19 activity. Week 20, ending May 16, 2020. (Accessed 5/24/20, at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/pdf/covidview-05-22-2020.pdf.)
•   Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19). Symptoms of Coronavirus. (Accessed 5/20/20, at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.)
•   Centers for Disease Control and Prevention. U.S. Influenza Surveillance System: Purpose and Methods. (Accessed 5/22/20, at https://www.cdc.gov/flu/weekly/overview.htm.)
•   Johns Hopkins University & Medicine. Coronavirus Resource Center. COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU CSSE). at https://coronavirus.jhu.edu/map.html.)
•   McKenna M. "Covid near you" crowdsources data to predict new hot spots. Wired.com 4/28/20.