Clinical Trial for Use of a Wearable Diagnostic for Very Early Symptomatic Detection of COVID-19 Infection is Now Actively Recruiting

MTEC Prime Awardee: Philips North America, LLC

The pandemic COVID-19, a disease caused by a novel coronavirus, continues to spread worldwide. There is a dire and urgent need for the development of rapid, accurate wearable diagnostics to identify and isolate pre- and early symptomatic COVID-19 cases and track and prevent the spread of the virus. Through MTEC’s 20-12-COVID-19_Diagnostics Request for Project Proposals, the U.S. Army Medical Research and Development Command (USAMRDC) issued awards to several organizations to develop wearable diagnostic capabilities for the pre-/very early-symptomatic detection of COVID-19 infection.

Philips North America, LLC, an MTEC member and global leader in medical technology, has created a public-private partnership with BioIntelliSense, the University of Wisconsin, eTrueNorth, the U.S. Department of Health and Human Services (HHS), and USAMRDC. This MTEC project led by Philips is funded to “recruit 2,500 volunteers from 22 testing sites located at the University of Wisconsin facilities. Participants in the study will be shipped BioIntelliSense’s BioSticker medical device (with its BioHub wireless gateway) that will be worn for 14 days to continuously capture and monitor the participants’ temperature, respiration rate at rest, heart rate at rest, sleep/rest/active state, body position, and/or coughing frequency.1” This information will be used to determine the device’s effectiveness for detecting and monitoring COVID-19 infection. The deliverable at the end of the period of performance is to obtain Emergency Use Authorization for the wearable capability and be ready to distribute the device.

This study is now actively recruiting for participants. “To qualify for participation in this study, individuals must have received a COVID-19 test in the past 24 hours for one of the following reasons:

  • Recent high-risk exposure to known COVID-19 infected individual(s) within the past 72 hours
  • Recent onset of COVID-19 symptoms within the past 72 hours

Individuals may learn more about the study eligibility and enroll online at www.BioStickerCOVIDstudy.com.

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