COVID-RED’s wearable tech is intended to be able to track variables like skin temperature and breathing rate, potentially spotting early cases of Covid-19 for timely testing
The highest viral load is expelled by infected individuals in the 48 hours prior to their first report of initial symptoms, says Rick Grobbee, Professor of Clinical Epidemiology at the University Medical Centre, Utrecht. This is a vital period in early detection of disease. The newly-launched IMI project coordinated by Prof. Grobbee, COVID-RED, is developing a wearable technology which, combined with advances in machine learning, aims to warn users who may be ill with COVID-19 (including those without symptoms) to isolate, or seek medical testing sooner than they otherwise would. They expect to launch a clinical trial to collect data for the detection system as early as November 2020.
The clinical trial will recruit 40,000 people across both the Netherlands and Liechtenstein and run until mid-2021. Depending on results from this trial, they hope to have the COVID-RED system available for public use within 12 to 18 months.
How will it be used, and who will use it?
An end user would purchase (or in the case of this study, be given) an Ava bracelet, a wearable device, worn like a watch, that is typically used by women to track fertility. The wearable device is equipped with multiple sensors that communicates with a specifically designed smartphone app and its underlying algorithm. “After downloading the COVID-RED app and providing optional additional information about their risk level (e.g., pre-existing conditions),” says Dr Brianna Goodale, Managing Director of Ava-COVID, “the user then syncs the device to the app.”
“Worn only at night while the user sleeps, the Ava bracelet continually tracks changes in physiological parameters associated with early signs of COVID-19 infection, including resting pulse rate, breathing rate and skin temperature.”
Upon waking, the user would sync their Ava bracelet to the mobile app, which reads the raw data via Bluetooth. The algorithm will then take the user’s nightly changes in physiological parameters as signal inputs and provide the user with real-time feedback about the possibility of developing or potential infection.
“For example, the user may not feel feverish or unwell, but the algorithm will be sensitive enough to detect objective changes in temperature and alert the user if those trends significantly differ from their baseline parameters,” explains Dr Goodale. “In the app, the user can also report the presence and severity of symptoms, along with any potential confounds that could affect the algorithm’s accuracy, like having drunk alcohol or taken medications to reduce fever the night before. Based on the algorithm’s recommendation, the user could choose to self-isolate, consult with a medical professional and/or decide whether further testing in line with national guidelines was warranted.”
Filling a critical gap in the medical response to the virus
The bracelet may also allow people working in emergency departments in hospitals to rest assured that they will not unintentionally expose colleagues or patients by showing up to work while pre-symptomatic. “You could imagine, for example,” says Dr Goodale, “that an emergency medicine nurse enrols in our clinical study and wears the Ava bracelet nightly. While the nurse wears protective gear during shifts and follows all hospital guidelines to minimise transmission, he or she is nevertheless interacting with confirmed COVID-19 patients daily. Wearing the bracelet may provide some peace of mind that they will be alerted as soon as their biophysical parameters change, ahead of when they could first feel unwell. They may even opt for early testing, based on the algorithm’s recommendations.”
She adds, “We believe that this makes the system an ideal candidate during screening point-of-care and at-home symptom monitoring. The Ava bracelet and complementary COVID-RED app provide a solution to a critical gap in the medical response to this virus: namely, at-home detection and in-treatment remote surveillance of vital signs.”
Adapting to a shifting landscape
The constantly changing landscape of the COVID-19 pandemic will be a challenge for Prof Grobbee and the team. “While we can plan a protocol and develop the system based on what information is available today, it is quite likely that factors like national testing guidelines and standard of care procedures will evolve as we learn more about the SARS-CoV-2 virus.”
“In any randomised clinical trial, a good scientist tries to control as many extraneous variables as possible so as to best isolate and test the potential impact of an intervention on desired outcomes. In our case, that would mean assuming over the next 18 months that the virus will not substantially mutate, that national guidelines will not change, and that an effective treatment or vaccine will not be found. However, we know this cannot be the case.”
Like everyone, the team behind COVID-RED are hoping for a treatment that can combat the virus early on while being aware that the changing face of the pandemic may mean that diagnostic criteria or protocols for testing may change. Thus, it may be that over the course of the clinical trial the system is adapted to, for example, change how it alerts users to seek testing or provide advice on newly developed prophylactic medications.
“While we cannot predict or plan for how the virus and our context will change over the coming year, we recognise that this is a cost of participating in cutting-edge research in a time of global need and are remaining flexible while ensuring we conduct as rigorous scientific inquiry as possible.”