Clinical trial NCT04331509: COVID-19 Symptom Tracker
Official title: COVID-19 Symptom Tracker
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: COVID-19
Coronovirus
Symptom tracker
Virus
Pandemic
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Zoe Global Limited
name: Massachusetts General Hospital
name: Harvard School of Public Health (HSPH)
name: Stanford University
First posted: 2020-04-02
Enrollment: 10000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Physical health symptoms
timeFrame: 1 day
measure: Lack of physical health symptoms
timeFrame: 1 day
Secondary outcomes:
measure: Fever
timeFrame: 1 day
Other outcomes:
measure: Cough
timeFrame: 1 day
measure: Fatigue
timeFrame: 1 day
measure: Headache
timeFrame: 1 day
measure: Shortness of breath
timeFrame: 1 day
measure: Sore throat
timeFrame: 1 day
measure: Loss of smell/ taste
timeFrame: 1 day
measure: Hoarse voice
timeFrame: 1 day
measure: Chest pain or tightness
timeFrame: 1 day
measure: Abdominal pain
timeFrame: 1 day
measure: Diarrhoea
timeFrame: 1 day
measure: Confusion
timeFrame: 1 day
measure: Skipping meals
timeFrame: 1 day
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Tim D Spector
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.