COVID-19 Symptom Tracker

The viral Covid-19 outbreak is now considered a pandemic according to the World Health Organisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developed to record and monitor the symptoms of the COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing are affecting the mental health and well-being of participants. The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: No Intervention

Detailed Description

A free monitoring app 'COVID-19 Symptom Tracker' has been developed by health technology company Zoe Global Limited in collaboration with scientists at King's College London, Harvard Medical School, Massachusetts General Hospital and Stanford University. A web-based equivalent is being developed for those unable to download this app. This new app records and monitors the symptoms of COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing affect the mental health and well-being of participants. The app also allows self-reporting where no symptoms are experienced such that it records any users that feel healthy and normal.

The app, has been launched in both the UK and the US. Researchers in other countries are encouraged to obtain the required approvals from Apple and Google to make the app available in their territories.

The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.

It is also hoped that the data generated from this study will help the urgent clinical need to distinguish mild coronavirus symptoms from seasonal coughs and colds, which may be leading people to unnecessarily self-isolate when they aren't infected or inadvertently go out and spread the disease when they are.

Users download the free app COVID-19 Symptom Tracker and record information about their health on a daily basis, including temperature, tiredness and symptoms such as coughing, breathing problems or headaches.

The app is available internationally to the general population and will also be used in two large epidemiological cohorts: The TwinsUK cohort (n=15,000) and Nurses Health Study (n=280,000).

The app will allow scientists to study the spread and development of symptoms across whole populations, both in the UK and abroad, as well as detailed genetic and other studies, particularly with the twins cohort

Any data gathered from the app and study will be used strictly for public health or academic research and will not be used commercially or sold.

• Study Type: Observational
• Enrollment (Anticipated): 10000000

Contacts and Locations

• Study Contact: Name: Victoria Vazquez; Phone Number: 02071886765; Email: victoria.vazquez@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • King's College London
    • Contact: Victoria Vazquez; Phone Number: 020 7188 6765; Email: victoria.vazquez@kcl.ac.uk
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: David A Drew, PhD; Email: predict@mgh.harvard.edu
      • Contact: Andrew T. Chan, MD
      • Principal Investigator: Andrew Chan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Anyone who is able to download the app or use the web-based equivalent tool to self-report their symptoms.

Description

Inclusion Criteria:

• Adults of 18 years and above, both in the UK and internationally where the app has been approved for download from the Apple App store and Google Play. The web-based equivalent to the app will also be made available via a link for those unable to download.

Exclusion Criteria:

• Anyone below the age of 18; anyone unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptom tracker users; No Intervention	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical health symptoms	Self reported as physically healthy (tick box)	1 day
Lack of physical health symptoms	Self reported as physically not feeling healthy (tick box)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever	Self reported remperature (Degrees Celsius)	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough	Self reported cough (drop down menu; yes/no)	1 day
Fatigue	Self reported fatigue (drop down menu; yes/no)	1 day
Headache	Self reported headache (drop down menu; yes/no)	1 day
Shortness of breath	Self reported shortness of breath (drop down menu; yes/no)	1 day
Sore throat	Self reported sore throat (drop down menu; yes/no)	1 day
Loss of smell/ taste	Self reported loss of smell/ taste (drop down menu; yes/no)	1 day
Hoarse voice	Self reported hoarse voice (drop down menu; yes/no)	1 day
Chest pain or tightness	Self reported chest pain or tightness (drop down menu; yes/no)	1 day
Abdominal pain	Self reported abdominal pain (drop down menu; yes/no)	1 day
Diarrhoea	Self reported diarrhoea (drop down menu; yes/no)	1 day
Confusion	Self reported confusion (drop down menu; yes/no)	1 day
Skipping meals	Self reported skipping meals (drop down menu; yes/no)	1 day

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Massachusetts General Hospital; Stanford University; Harvard School of Public Health (HSPH); Zoe Global Limited
• Investigators: Principal Investigator: Tim D Spector, King's College London

Publications and helpful links

General Publications

• Lo CH, Nguyen LH, Drew DA, Warner ET, Joshi AD, Graham MS, Anyane-Yeboa A, Shebl FM, Astley CM, Figueiredo JC, Guo CG, Ma W, Mehta RS, Kwon S, Song M, Davies R, Capdevila J, Sudre CH, Wolf J, Cozier YC, Rosenberg L, Wilkens LR, Haiman CA, Marchand LL, Palmer JR, Spector TD, Ourselin S, Steves CJ, Chan AT; COPE Consortium. Race, ethnicity, community-level socioeconomic factors, and risk of COVID-19 in the United States and the United Kingdom. EClinicalMedicine. 2021 Aug;38:101029. doi: 10.1016/j.eclinm.2021.101029. Epub 2021 Jul 17.
• Nguyen LH, Drew DA, Graham MS, Joshi AD, Guo CG, Ma W, Mehta RS, Warner ET, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Sudre CH, Cardoso MJ, Wolf J, Spector TD, Ourselin S, Steves CJ, Chan AT; COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet Public Health. 2020 Sep;5(9):e475-e483. doi: 10.1016/S2468-2667(20)30164-X. Epub 2020 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Anticipated): March 23, 2023
• Study Completion (Anticipated): March 23, 2023

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Virus; Pandemic; Coronovirus; Symptom tracker
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-19 Symptom tracker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Access to the COVID-19 Symptom Tracker data will be given to members of the clinical or scientific community as outlined below in accordance with the following privacy policies:

https://covid.joinzoe.com/privacy-notice

https://storage.googleapis.com/covid-symptom-tracker-public/privacy-policy-us.pdf

• IPD Sharing Time Frame: Immediately

IPD Sharing Access Criteria

Request to access the COVID-19 Symptom Tracker data should made by submitting an online Data Access Application Form. The form is available on the TwinsUK website.

https://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ

Decision Process & Outcome:

Upon submission of the Covid-19 Data Application Form, the TwinsUK data management team will review the application forms received and information on the outcome will be provided within a week. Decisions on the most complex applications will be overseen by the TwinsUK Resource Executive Committee.

All applicants must belong to the clinical or scientific community, present a valid rationale and must have

• A healthcare email address
• An educational email address
• A track of peer reviewed publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No