Digital healthcare company Ava is set to commence the study of a wearable fertility tracker device to detect Covid-19 infection in real-time and alert individuals to get tested or self-isolate prior to symptom onset.
The Ava Fertility Tracker is primarily an FDA-cleared and CE-marked fertility tracking device for assessing and displaying physiological parameters to aid in conception and offer general data on health and wellness to users.
Worn only during sleep, the bracelet can track various physiological parameters such as pulse rate, breathing rate and skin temperature.
The COVID-19: Rapid Early Detection (COVID-RED) clinical trial will analyse the real-life, real-time efficacy of Ava’s device to aid in stopping virus spread during the pre-symptomatic phase.
The researchers will assess how precisely the bracelet and complementary app can detect a Covid-19 infection before the onset of symptoms.
In the study, more than 20,000 subjects across general and high-risk populations will be provided with an Ava bracelet. Recruitment began in February and is planned to run through December.
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Subjects will wear the Ava bracelet for up to nine months during sleep, and upon waking, they will be able to see an AI-generated indicator reflecting their overall health status.
The algorithm displays indicators of wellness dependant on changes in physiological parameters. Ava will provide asymptomatic subjects detected as potentially ill by the app with access to a diagnostic test.
In a retrospective analysis of data from their COVI-GAPP pilot trial, Ava’s Covid-19 infection detection algorithm was demonstrated to accurately detect 71% of positive cases two days prior to symptom onset.
Ava CEO and co-founder Lea von Bidder said: “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 wellbeing.”