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COVID-19 Symptom Tracker

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ClinicalTrials.gov Identifier: NCT04331509
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
Zoe Global Limited
Massachusetts General Hospital
Harvard School of Public Health
Stanford University
Information provided by (Responsible Party):
King's College London

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 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.

Condition or disease Intervention/treatment
COVID-19 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.

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Study Type : Observational
Estimated Enrollment : 10000000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Symptom Tracker
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 23, 2022

Group/Cohort Intervention/treatment
Symptom tracker users
No Intervention
Other: No Intervention
No Intervention




Primary Outcome Measures :
  1. Physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically healthy (tick box)

  2. Lack of physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically not feeling healthy (tick box)


Secondary Outcome Measures :
  1. Fever [ Time Frame: 1 day ]
    Self reported remperature (Degrees Celsius)


Other Outcome Measures:
  1. Cough [ Time Frame: 1 day ]
    Self reported cough (drop down menu; yes/no)

  2. Fatigue [ Time Frame: 1 day ]
    Self reported fatigue (drop down menu; yes/no)

  3. Headache [ Time Frame: 1 day ]
    Self reported headache (drop down menu; yes/no)

  4. Shortness of breath [ Time Frame: 1 day ]
    Self reported shortness of breath (drop down menu; yes/no)

  5. Sore throat [ Time Frame: 1 day ]
    Self reported sore throat (drop down menu; yes/no)

  6. Loss of smell/ taste [ Time Frame: 1 day ]
    Self reported loss of smell/ taste (drop down menu; yes/no)

  7. Hoarse voice [ Time Frame: 1 day ]
    Self reported hoarse voice (drop down menu; yes/no)

  8. Chest pain or tightness [ Time Frame: 1 day ]
    Self reported chest pain or tightness (drop down menu; yes/no)

  9. Abdominal pain [ Time Frame: 1 day ]
    Self reported abdominal pain (drop down menu; yes/no)

  10. Diarrhoea [ Time Frame: 1 day ]
    Self reported diarrhoea (drop down menu; yes/no)

  11. Confusion [ Time Frame: 1 day ]
    Self reported confusion (drop down menu; yes/no)

  12. Skipping meals [ Time Frame: 1 day ]
    Self reported skipping meals (drop down menu; yes/no)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331509


Contacts
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Contact: Victoria Vazquez 02071886765 victoria.vazquez@kcl.ac.uk

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: David A Drew, PhD       predict@mgh.harvard.edu   
Contact: Andrew T. Chan, MD         
Principal Investigator: Andrew Chan         
United Kingdom
King's College London Recruiting
London, United Kingdom, SE1 7EH
Contact: Victoria Vazquez    020 7188 6765    victoria.vazquez@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Zoe Global Limited
Massachusetts General Hospital
Harvard School of Public Health
Stanford University
Investigators
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Principal Investigator: Tim D Spector King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04331509    
Other Study ID Numbers: COVID-19 Symptom tracker
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Time Frame: Immediately
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
URL: https://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ

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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:
COVID-19
Coronovirus
Symptom tracker
Virus
Pandemic