The company eTrueNorth https://etruenorth.com based in the U.S is partnering with HHS, University of Wisconsin, Philips https://www.isa.philips.com, and BioIntelliSense Inc. https://biointellisense.com under an Army Medical Research Development Command (USAMRDC) award. The plan is to validate the BioIntelliSense’s BioSticker https://www.BioStickerCOVIDstudy.com device in a clinical trial to detect COVID-19 symptoms early.
According to James Mault, MD, Founder and CEO BioIntelliSense, “The medical grade BioSticker wearable, combined with advanced diagnostic algorithms, may serve as the basis for identifying pre- and very early symptomatic COVID-19 cases. This will enable infected individuals to receive treatment earlier and also reduce the spread of the virus to others.”
The USARMRDC funded clinical trial hopes to recruit 2,500 volunteers from 22 testing sites located at University of Wisconsin facilities. Participants in the study will be shipped the BioIntelliSense BioSticker with the BioHub wireless gateway that will continuously capture vital signs for 14 consecutive days.
Rapid testing being funded by HHS uses eTrueNorth’s technology platform so that individuals can find a nearby location, schedule an appointment, print a voucher, so that when they arrive onsite, the test results will be provided in about 10 minutes.
The study will last 14 days. During that time, study participants will complete the study remotely from home. The FDA-cleared BioSticker medical device will work discreetly on the upper left chest for a simplistic patient experience. The wearable continuously monitors vital signs, skin temperature, heart rate, respiratory rate at rest, and cough frequency
To qualify for participation in the study, individuals must have received a COVID-19 test in the past 24 hours for one of the following:
- Recent high risk exposure to known COVID-19 infected individuals within the past 72 hours
- Recent onset of COVID-19 symptoms within the past 72 hours
Also, participants must be 18 or older, English speaking adults, non-chronic daily user of non-steroidal anti-inflammatory medications and antipyretic medications and have access to a smartphone and/or internet access for completion of the daily survey.