In this project, we will evaluate the use and performance of a CE-marked device (wearable), which uses sensors to measure breathing rate, pulse rate, skin temperature, and heart rate variability for the purpose of early detection and monitoring of COVID-19 in general and high-risk populations. At the same time, a mobile application will be used to track participant-reported symptoms.
A prospective, observational study will follow 13,000 individuals from the general population and 7,000 high-risk individuals wearing the device and responding to participant self-report parameters via a purpose-designed app. Based on this data, an algorithm will indicate which individuals likely require general practitioner (GP) care (for COVID-19 diagnostic testing, further vital signs assessment, and/or treatment) and/or hospital care.
To evaluate algorithm performance, the cohort will be tested for COVID-19 antibodies at the end of followup, with stored baseline samples of participants who have tested positive also being tested to determine whether the participant was already positive at baseline or was exposed to SARS-CoV-2 during follow-up. COVID-19 seropositivity in the intervention cohort will be compared to seropositivity in a control population of 10,000 individuals drawn from the same populations using an application only. Thus, this project will deliver a large body of information on COVID19 PCR testing and antibodies that can be used to develop additional diagnostics and therapeutics in addition to validating remote vital signs and self-reported symptoms monitoring systems.
In summary, the overall objectives of this project are:
- To assess the diagnostic and prognostic value of monitoring vital signs (such as breathing rate, pulse rate, skin temperature, and heart rate variability) by bracelet in users at home (for early COVID-19 case identification).
- To monitor individuals after the diagnosis to detect deterioration and that are under medical supervision (for early identification of COVID-19 patients requiring mechanical ventilation and/or intensive care) (WP 1)
- To study the added value of these remotely measured vital signs to the patient reported outcomes (WP3)
- To assess on the economic and clinical effects of monitoring vital signs for the early detection of COVID19 and in the detection of deterioration after the diagnosis (WP4)
- To generate a large database on vital signs and symptoms over time, and health care usage, that can be linked to COVID-19 antibody presence (as a marker of past COVID-19 infection) at the end of the data collection period (WP2)
- To deliver large open-source databases that are GDPR compliant (WP5)
- To partner with stakeholders and other related projects to create a network and maximize project impact (WP6)
- To ensure the efficient & effective management of the consortium and sustainability of results, in compliance with the Grant Agreement and Consortium Agreement. (WP7)