Ava, a digital healthcare company that focuses on women’s reproductive health, announced today it will be launching the first study of its kind to 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 to date (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, the COVID-19: Rapid Early Detection (COVID-RED) clinical trial takes the research to the next step — testing real-life, real-time efficacy of Ava’s device (currently 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 accurately detect 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 through 2021 to further improve its accuracy.
In addition, Ava is the only wearable currently leveraged in the fight against COVID-19 designed with a deep understanding of the science behind female physiology — a unique advantage, since researchers will be able to take menstrual cycle changes in multiple physiological parameters including skin temperature into account 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,” says 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 Will Test Ava-Developed Algorithm in Early Detection
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 through December 2021.
Participants will wear the Ava 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 like 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. 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,” said Ava CEO and Co-founder Lea von Bidder. “We believe our deep understanding of female physiology gives us a unique advantage over other wearables in helping solve this global health challenge.”
According to von Bidder, 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 generalized to women, we are flipping the script at Ava — understanding women’s physiology first, then adapting algorithms to generalize to the whole population.”
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. To learn more about the COVID-RED study, visit www.covid-red.eu.
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 personalized insight about reproductive health and pregnancy. Worn only during sleep, the Ava bracelet* tracks multiple physiological parameters including pulse rate, breathing rate, and skin temperature. Launched in the US in 2016, the Ava bracelet is now sold in 36 countries and has helped more than 50,000 women become pregnant. Studies for the clinical use of Ava have been conducted in collaboration with academic partners around the world, including at the University Hospital of Zurich, Switzerland, Columbia University, and Northwestern University’s Feinberg School of Medicine. Ava was voted Best of Baby Tech at CES, named a Women’s Health “Editors’ Choice” product and has been honored as a CB Insights Digital Health 150 company. For more information on Ava, visit www.avawomen.com.
*The Ava Fertility Tracker is the only FDA-cleared fertility tracking wearable and is also CE-marked according to MDD 93/42/EC for the purpose of measuring and displaying physiological parameters to facilitate conception and to provide general information on health and wellness to users.