COVID-19 Symptom Tracker

COVID-19 Clinical Trial

Official title:

COVID-19 Symptom Tracker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331509
• Other study ID #: COVID-19 Symptom tracker
• Status: Recruiting
• Start date: March 23, 2020
• Est. completion date: March 23, 2023

Study information

• Verified date: March 2022
• Source: King's College London
• Contact: Victoria Vazquez
• Phone: 02071886765
• Email: victoria.vazquez[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000000
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
United Kingdom	King's College London	London
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cough	Self reported cough (drop down menu; yes/no)	1 day
Other	Fatigue	Self reported fatigue (drop down menu; yes/no)	1 day
Other	Headache	Self reported headache (drop down menu; yes/no)	1 day
Other	Shortness of breath	Self reported shortness of breath (drop down menu; yes/no)	1 day
Other	Sore throat	Self reported sore throat (drop down menu; yes/no)	1 day
Other	Loss of smell/ taste	Self reported loss of smell/ taste (drop down menu; yes/no)	1 day
Other	Hoarse voice	Self reported hoarse voice (drop down menu; yes/no)	1 day
Other	Chest pain or tightness	Self reported chest pain or tightness (drop down menu; yes/no)	1 day
Other	Abdominal pain	Self reported abdominal pain (drop down menu; yes/no)	1 day
Other	Diarrhoea	Self reported diarrhoea (drop down menu; yes/no)	1 day
Other	Confusion	Self reported confusion (drop down menu; yes/no)	1 day
Other	Skipping meals	Self reported skipping meals (drop down menu; yes/no)	1 day
Primary	Physical health symptoms	Self reported as physically healthy (tick box)	1 day
Primary	Lack of physical health symptoms	Self reported as physically not feeling healthy (tick box)	1 day
Secondary	Fever	Self reported remperature (Degrees Celsius)	1 day