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COVID-19 Symptom Tracker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 31, 2020
First Posted Date April 2, 2020
Last Update Posted Date April 7, 2020
Actual Study Start Date March 23, 2020
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2020)
  • Physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically healthy (tick box)
  • Lack of physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically not feeling healthy (tick box)
Original Primary Outcome Measures
 (submitted: March 31, 2020)
  • Physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically healthy
  • Lack of physical health symptoms [ Time Frame: 1 day ]
    Self reported as physically not feeling healthy
Change History
Current Secondary Outcome Measures
 (submitted: April 3, 2020)
Fever [ Time Frame: 1 day ]
Self reported remperature (Degrees Celsius)
Original Secondary Outcome Measures
 (submitted: March 31, 2020)
Fever [ Time Frame: 1 day ]
Self reported remperature
Current Other Pre-specified Outcome Measures
 (submitted: April 2, 2020)
  • Cough [ Time Frame: 1 day ]
    Self reported cough (drop down menu; yes/no)
  • Fatigue [ Time Frame: 1 day ]
    Self reported fatigue (drop down menu; yes/no)
  • Headache [ Time Frame: 1 day ]
    Self reported headache (drop down menu; yes/no)
  • Shortness of breath [ Time Frame: 1 day ]
    Self reported shortness of breath (drop down menu; yes/no)
  • Sore throat [ Time Frame: 1 day ]
    Self reported sore throat (drop down menu; yes/no)
  • Loss of smell/ taste [ Time Frame: 1 day ]
    Self reported loss of smell/ taste (drop down menu; yes/no)
  • Hoarse voice [ Time Frame: 1 day ]
    Self reported hoarse voice (drop down menu; yes/no)
  • Chest pain or tightness [ Time Frame: 1 day ]
    Self reported chest pain or tightness (drop down menu; yes/no)
  • Abdominal pain [ Time Frame: 1 day ]
    Self reported abdominal pain (drop down menu; yes/no)
  • Diarrhoea [ Time Frame: 1 day ]
    Self reported diarrhoea (drop down menu; yes/no)
  • Confusion [ Time Frame: 1 day ]
    Self reported confusion (drop down menu; yes/no)
  • Skipping meals [ Time Frame: 1 day ]
    Self reported skipping meals (drop down menu; yes/no)
Original Other Pre-specified Outcome Measures
 (submitted: March 31, 2020)
  • Cough [ Time Frame: 1 day ]
    Self reported cough
  • Fatigue [ Time Frame: 1 day ]
    Self reported fatigue
  • Headache [ Time Frame: 1 day ]
    Self reported headache
  • Shortness of breath [ Time Frame: 1 day ]
    Self reported shortness of breath
  • Sore throat [ Time Frame: 1 day ]
    Self reported sore throat
  • Loss of smell/ taste [ Time Frame: 1 day ]
    Self reported loss of smell/ taste
  • Hoarse voice [ Time Frame: 1 day ]
    Self reported hoarse voice
  • Chest pain or tightness [ Time Frame: 1 day ]
    Self reported chest pain or tightness
  • Abdominal pain [ Time Frame: 1 day ]
    Self reported abdominal pain
  • Diarrhoea [ Time Frame: 1 day ]
    Self reported diarrhoea
  • Confusion [ Time Frame: 1 day ]
    Self reported confusion
  • Skipping meals [ Time Frame: 1 day ]
    Self reported skipping meals
 
Descriptive Information
Brief Title COVID-19 Symptom Tracker
Official Title COVID-19 Symptom Tracker
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition COVID-19
Intervention Other: No Intervention
No Intervention
Study Groups/Cohorts Symptom tracker users
No Intervention
Intervention: Other: No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 31, 2020)
10000000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 23, 2022
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Victoria Vazquez 02071886765 victoria.vazquez@kcl.ac.uk
Listed Location Countries United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04331509
Other Study ID Numbers COVID-19 Symptom tracker
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party King's College London
Study Sponsor King's College London
Collaborators
  • Zoe Global Limited
  • Massachusetts General Hospital
  • Harvard School of Public Health
  • Stanford University
Investigators
Principal Investigator: Tim D Spector King's College London
PRS Account King's College London
Verification Date March 2020