Swiss women’s reproductive health company Ava is starting a clinical trial to evaluate the effectiveness of its fertility tracking sensor bracelet for detecting Covid-19.

The study will test whether a wearable device can detect a Covid-19 infection in real time and alert people to get tested or self-isolate prior to showing symptoms.

While other studies, including the Covi-Gapp study Ava announced in April 2020, have examined the feasibility of using machine learning and wearable devices to retrospectively detect Covid-19 infection, this rapid early detection (Covid-Red) clinical trial takes the research to the next step by testing the real-life, real-time efficacy of Ava’s device used primarily for fertility tracking in helping stop the spread of the virus during its pre-symptomatic phase.

Researchers will evaluate how well the bracelet and complementary app identify a Covid-19 infection prior to symptom onset.

In a retrospective analysis of data from the Covi-Gapp pilot trial, Ava’s Covid-19 infection detection algorithm was shown to detect accurately 71% of Covid-19 positive infections two days prior to symptom onset. Ava expects the algorithm to perform similarly in the initial phase of the Covid-Red study, and iterative updates to the algorithm are planned during 2021 to improve its accuracy.

In addition, as Ava was designed with an understanding of the science behind female physiology, researchers will be able to take into account menstrual cycle changes in multiple physiological parameters including skin temperature to prevent reporting false positives.

“This is a real breakthrough in the early detection of Covid-19 infection and in the fight against the pandemic,” said Dr Lorenz Risch, “because one of the big challenges is to identify virus carriers as early as possible. A lot of people who catch Covid-19 only show symptoms days afterwards, so the virus is often passed on unknowingly, which aids its spread and makes effective tracking difficult. The situation has been made even more difficult by the emergence of virus mutations that seem to spread more quickly from person to person than the original strain. Early detection is therefore increasingly important.”

More than 20,000 participants of all genders and across general and high-risk populations will be provided with an Ava bracelet in the study, which began recruiting in February and is expected to run until December 2021.

Participants will wear the bracelet for up to nine months nightly while they sleep; upon waking, they will be able to see an AI-generated indicator reflecting their overall health status. The underlying algorithm, based on changes in their physiological parameters over the preceding few days and/or self-reported symptoms, will display one of three possible indicators: no change in wellness detected; some minor changes in symptoms detected with the suggestion to stay home and self-isolate; or changes in symptoms and/or biophysical data detected that could signal a potential Covid-19 infection.

Partnering with other consortium members including Roche and Sanquin, Ava will provide asymptomatic participants identified as potentially ill by the app with access to a diagnostic test, ideally enabling them to self-isolate and prevent infecting others.

“Ava has helped tens of thousands of women around the world conceive and start families since launching in 2016,” said Ava CEO Lea von Bidder. “Now we are taking the power of our scientific expertise and technology to join in the fight against Covid-19 in a way no other wearable medical device has yet, by testing our infection detection algorithm in real time, providing bracelet wearers with daily updates about their health and well-being. We believe our deep understanding of female physiology gives us a unique advantage over other wearables in helping solve this global health challenge.”

Ava’s Covid-19 initial infection detection algorithm was trained on data from almost 500 women using the Ava fertility tracker who reported an infection in-app.

“While historically medical research has relied on data and research using male participants then generalised to women, we are flipping the script at Ava – understanding women’s physiology first, then adapting algorithms to generalise to the whole population,” said von Bidder.

Funded by the Innovative Medicines Initiative 2 Joint Undertaking, the Covid-Red consortium is a collaboration bringing together global experts in public health, epidemiology, biomedical informatics, wearable sensor technology and machine learning from the private and public sectors. Members of the consortium include Ava, Julius Clinical Research, Labormedizinisches Zentrum Dr Risch Ostschweiz, Roche Diagnostics Nederland (Roche), Stichting Sanquin Bloedvoorziening (Sanquin), Takeda Pharmaceuticals International (Takeda), University College London (UCL), Universitair Medisch Centrum Utrecht (UMC Utrecht), and Vive.

Ava is a digital health company with offices in Zurich, San Francisco, Belgrade and Makati that advances women’s reproductive health by bringing together artificial intelligence and clinical research. Its fertility tracking sensor bracelet detects the five most fertile days of a woman’s cycle in real time with 90% accuracy, while also delivering personalised insight about reproductive health and pregnancy.

Worn only during sleep, the bracelet tracks multiple physiological parameters including pulse rate, breathing rate and skin temperature. It is sold in 36 countries and has helped more than 50,000 women become pregnant. It is the only FDA-cleared fertility tracking wearable and is CE-marked for measuring and displaying physiological parameters to facilitate conception and to provide general information on health and wellness to users.