COVID-19 Symptom Tracker

Sponsor
King's College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04331509
Collaborator
Zoe Global Limited (Other), Massachusetts General Hospital (Other), Harvard School of Public Health (HSPH) (Other), Stanford University (Other)
10,000,000
2
36
5000000
138984

Study Details

Study Description

Brief Summary

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 infectionÍž 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
10000000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COVID-19 Symptom Tracker
Actual Study Start Date :
Mar 23, 2020
Anticipated Primary Completion Date :
Mar 23, 2023
Anticipated Study Completion Date :
Mar 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Symptom tracker users

No Intervention

Other: No Intervention
No Intervention

Outcome Measures

Primary Outcome Measures

  1. Physical health symptoms [1 day]

    Self reported as physically healthy (tick box)

  2. Lack of physical health symptoms [1 day]

    Self reported as physically not feeling healthy (tick box)

Secondary Outcome Measures

  1. Fever [1 day]

    Self reported remperature (Degrees Celsius)

Other Outcome Measures

  1. Cough [1 day]

    Self reported cough (drop down menu; yes/no)

  2. Fatigue [1 day]

    Self reported fatigue (drop down menu; yes/no)

  3. Headache [1 day]

    Self reported headache (drop down menu; yes/no)

  4. Shortness of breath [1 day]

    Self reported shortness of breath (drop down menu; yes/no)

  5. Sore throat [1 day]

    Self reported sore throat (drop down menu; yes/no)

  6. Loss of smell/ taste [1 day]

    Self reported loss of smell/ taste (drop down menu; yes/no)

  7. Hoarse voice [1 day]

    Self reported hoarse voice (drop down menu; yes/no)

  8. Chest pain or tightness [1 day]

    Self reported chest pain or tightness (drop down menu; yes/no)

  9. Abdominal pain [1 day]

    Self reported abdominal pain (drop down menu; yes/no)

  10. Diarrhoea [1 day]

    Self reported diarrhoea (drop down menu; yes/no)

  11. Confusion [1 day]

    Self reported confusion (drop down menu; yes/no)

  12. Skipping meals [1 day]

    Self reported skipping meals (drop down menu; yes/no)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 King's College London London United Kingdom SE1 7EH

Sponsors and Collaborators

  • King's College London
  • Zoe Global Limited
  • Massachusetts General Hospital
  • Harvard School of Public Health (HSPH)
  • Stanford University

Investigators

  • Principal Investigator: Tim D Spector, King's College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT04331509
Other Study ID Numbers:
  • COVID-19 Symptom tracker
First Posted:
Apr 2, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by King's College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022