A Clinical Trial for People who have Received their First Dose of Pfizer or Moderna Covid Vaccine and are awaiting their second dose
Led by Philips, BioIntelliSense and University of Colorado Anschutz Medical Campus
Wearable Diagnostic for Detection of COVID-19 like Infection
The purpose of this clinical study is to detect the signs and symptoms of early COVID-19 like infection using the FDA-cleared BioSticker™ multi-parameter wearable device.
Join this Clinical Trial Today!
Study participation will last eight (8) days for the vaccination group or fourteen (14) days for the exposed or symptomatic participants and . During that time period, you will complete this study remotely, from the comfort of your home, and will be asked to complete the following activities:
• Wear the BioSticker device continuously for 24 hours per day for the duration of the study
• Complete a mobile or web-based health survey once per day
• At the conclusion of your study participation, you will return the BioSticker and BioHub devices in the pre-addressed, postage-paid envelope provided with study materials
Who qualifies for this study?
Pfizer or Moderna Vaccination group
Already received the 1st dose of the Pfizer or Moderna COVID-19 vaccine and scheduled to receive the 2nd dose.
Known exposure to COVID-19 or early symptoms group
• Someone seeking or received a COVID-19 test in the last 24 hours due to one of the following:
a. Concerned about a recent known exposure of COVID-19 in the past 24 hours
b. Concerned about symptoms related to a COVID-19 infection
• 12 years of age and older
• Both genders, all races and ethnic groups
• English speaking adult subjects only
• Must be able to comply with COVID-19 testing procedures and application of the BioSticker device
• Willing to sign the informed consent document and/or the HIPAA medical record release form.
• Non-chronic daily user of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
• Smartphone and/or internet access for completion of daily survey
Frequently Asked Questions
Q. Will I need to visit a doctor's office or medical facility to complete study visits?
A. No, this study will be conducted 100% remotely and will not require travel for study visits
Q. Will there be any medical staff to assist me if I have questions or need help with study-related illnesses?
A. Yes, there will be a licensed study nurse available to address any related concerns or health questions.
Q. Do I need to be tech savvy to participate?
A. No, the ClinTrialConnect patient portal solution is simple and intuitive to use. The BioSticker device is also designed for self-application
Q. Will I need to change my BioSticker daily?
A. No, patients will need to change the medical grade adhesives approximately every seven (7) days or when the adhesive loosens from the skin. Instructions for Use will accompany the BioSticker device that is provided to a participant and will used continuously for the duration of the study.
The FDA-cleared BioSticker medical device is designed to be discreetly worn on the upper left chest for a simplistic “stick it on and forget it” patient experience.
• Continuous vital sign monitoring of skin temperature, heart rate and respiratory rate at rest, and cough frequency
• Medical grade single-use device and replaceable adhesives
• Private and secure remote data capture and transmission via the BioHub™ gateway device
Physicians Overseeing the Study
Vik Bebarta, MD
Professor of Emergency Medicine-Medical Toxicology and Pharmacology at the University of Colorado - Anschutz School of Medicine
Dr. Vikhyat S. Bebarta is the Vice-Chair for Strategy and Growth, and Director for the CU Anschutz Center for COMBAT Research in the Department of Emergency Medicine. He is a Professor of Emergency Medicine (Medical Toxicology) and a tenured Professor of Pharmacology at the University of Colorado School of Medicine in Aurora, CO.
He is also a Colonel in the US Air Force Reserve, Office of the Chief Scientist, 59th Medical Wing, JBSA, Texas and former Medical Director and Flight Commander, Colorado Air National Guard and Medical Director and Flight Commander of the CERFP (CBRNE Enhanced Force Package) – Detachment 1 HQ.
He serves as chair or member of several National DoD Combat Casualty Care Steering Committees and Leadership Panels, and has published over 185 publications, delivered 200 national invited lectures or keynote addresses, and received several federal NIH and DoD clinical research grants.
James Mault, MD, FACS
Founder and CEO at BioIntelliSense, Inc.
Dr. Mault has more than 35 years of experience in senior executive positions in the health IT and medical device industry as well as clinical medicine.
He has founded five health IT and medical device companies, leading these companies to develop novel devices and software technologies and gain FDA approvals. He is the named inventor of over 80 issued and pending patents for a variety of health IT and medical device innovations.
Dr. Mault received his B.S. in Biology and Medical Degree from the University of Michigan and conducted his General Surgery and Cardiothoracic Surgery residency training at Duke University Medical Center.
He has been board-certified in both General Surgery and Cardiothoracic Surgery, having specialized in heart and lung transplantation, thoracic oncology and critical care.