King’s College London, along with collaborators including Zoe Global Limited, Harvard Medical School, Massachusetts General Hospital and Stanford Hospital, have launched a global observational clinical trial based on a free monitoring app called the ‘COVID-19 Symptom Tracker.’ The study team, thinking ambitiously, seeks to ultimately use this app with up to 10 million volunteers to monitor their COVID-19 coronavirus infection symptoms-tracking in real time how the disease progresses. The app can also measure other elements aimed at controlling the pandemic.
Studies targeting 10 million participants, even observational—are rare. Hence, at this critical juncture of the COVID-19 pandemic, TrialSite News breaks down this study for the TrialSite Network.
Who is the Study Sponsor?
King’s College London
Who are the Collaborators?
Zoe Global Limited (maker of the app) and major academic medical centers of Massachusetts General Hospital, Harvard School of Public Health and Stanford University
What is the Study Goal?
The sponsors and collaborators seek to understand more about this novel coronavirus impacts people; how does the disease manifest and what are the symptoms around the targeted countries which to start is the UK and US? How long do they last? Are certain symptoms associated with certain conditions associated with COVID-19? How does the disease progress in different people? By gender, ethnicity and nationality for example. The study team seeks to better understand why some people go on to develop more severe or fatal versions of the disease while others have only mild symptoms.
Importantly, the study sponsors seek to understand how to distinguish between mild coronavirus symptoms and the seasonal cold or cough, for example. This can lead people to self-isolate when they aren’t infected or inadvertently go out and spread the disease if they in fact believe they have a mere cold but actually have been infected with the disease.
Is the Study seeking to expand to other Nations?
Yes. The sponsor is encouraging researchers of other countries to obtain the required approvals from Apple and Google to make the app available in their territories.
How do Participants Obtain the App?
Users download the free app COVID-19 Symptom Tracker and record information about their healthy on a daily basis, including temperature, tiredness and symptoms such as coughing, breathing problems or headaches.
The app will be used in two large epidemiological cohorts: The TwinsUK cohort (n=15,000) and Nurses Health Study (n=280,000). The investigators can assess how the disease spreads and develops across these populations and will offer detailed genetic and other information they hope—especially with the twins’ cohort. The study commenced March 23, 2020 and runs through till March 23, 2022.
Who is Zoe Global Limited?
Founded in 2017, Zoe Global Limited positions itself as a nutrition science company. Based in London and Boston, its founders Tim Spector, Jonathan Wolf, and George Hadjigeorgiou all had a common interest in improving their health through what they ate—their diet. They eventually centered around Tim Spector’s research involving gut bacteria (microbiome) and precision-guided, personalized models. Hence, by combining scientific knowledge (Tim Spector) with machine learning and business expertise (Mr. Wolf and Mr. Hadjigeorgiou) augmented by nutrition researchers that form KLC and MGH, with which they now tout that they are heading the world’s largest scientific study of nutritional responses.
The company reports it is backed by well-capitalized private backers and currently employs about 50.
What about the Patient Data? What will it be used for?
The investigators note that the data will be used strictly for public health or academic research and they proclaim no data will be used commercially or sold.
Key Investigators & Contacts
Tim D. Spector, Professor Genetic Epidemiology, King’s College London
Victoria Vazquez, King’s College London
David A. Drew, PhD, Massachusetts General Hospital, Harvard Medical School
Andrew Chan, MD, MPH, Massachusetts General Hospital, Harvard Medical School
Call to Action: Note, the study contact is Victoria A. Vazquez. She can be reached at [email protected]