The goals of this study are 1) to validate the use of a wearable diagnostic capability and software as a medical device (SaMD) algorithm for the pre or early-symptomatic detection of COVID-19 infection, 2) assess the wearable device on the subjects, and 3) ensure data are collected, securely stored, and easily read and interpreted by non-laboratory personnel.
This is an open label iterative study designed to calibrate the algorithm to maximize its
test characteristics. The sample size is derived from the minimum number of COVID-19 subjects
required to evaluate algorithm sensitivity and specificity. A sample size of 200 true
positive COVID-19 infections is anticipated to assess device predictive analytics. Assuming a
six-month enrollment period, a 15 percent patient lost to follow-up rate, and a positive
COVID-19 infection rate of 10 percent within the study population, a sample size of 2,352
subjects will be enrolled in this prospective study.
Primary Outcomes: The primary outcomes of interest are performance of the BioSticker
multiparameter vital signs wearable and the sensitivity of the BioCloud-based algorithms in
detecting early onset of active COVID-19 related signs and symptom in subjects prior to or
coincident with a positive COVID-19 diagnostic test and the specificity of the BioSticker
algorithms in distinguishing positive diagnosis of infection from negative diagnosis of
infection among subjects. COVID-19 infection will be confirmed by both participant
affirmation and diagnostic laboratory testing. Additional primary outcome is the intuitive
presentation of affirmative diagnostic results from the BioSticker early detection
algorithm(s).
Secondary Outcomes: The secondary outcomes of interest include correlation of biometric data
indicators to individual-level experiential feedback reported through participant
symptom-tracking and diagnostic questionnaires.
Cohort 1- Exposed/ Early Symptomatic Group
Inclusion Criteria:
1. age 18 or older;
2. able to follow the study device wear instructions per the Instructions for Use;
3. no positive viral test within 60 days prior to enrollment; and
4. willing and able to provide written, informed consent.
Exclusion Criteria:
1. pregnant or breastfeeding;
2. wearing a defibrillator or pacemaker;
3. known or suspected cardiac dysrhythmias
4. known or suspected allergy to adhesives;
5. chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and
antipyretic medications
6. open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper
chest preventing placement of the biosensor; and
7. current or planned use of either an investigation pharmaceutical or an investigational
device during the study.
Cohort 1- Vaccine Group
Inclusion Criteria:
Subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series are eligible for
the study if they are:
1. Age 18 or older; 12 years of age -17 years of age are approved to participate in the
vaccine Cohort portion of the study.
2. scheduled to receive their first and second dose of the Pfizer/BioNTech or Moderna
COVID-19 vaccine
3. able to follow the study device wear instructions per the Instructions for Use;
4. no positive viral test within 60 days prior to enrollment; and
5. willing and able to provide written, informed consent.
6. Willing and able to take an oral temperature
Exclusion Criteria:
Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series will
be excluded from the study if they are or have any of the following:
1. pregnant or breastfeeding;
2. wearing a defibrillator or pacemaker;
3. known or suspected cardiac dysrhythmias
4. known or suspected allergy to adhesives;
5. chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and
antipyretic medications
6. open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper
chest preventing placement of the biosensor; and
7. current or planned use of either an investigation pharmaceutical or an investigational
device during the study.
8. previously fully vaccinated subjects
ClinOne, Inc
Greenwood Village, Colorado, United States
James Mault, MD, Principal Investigator
BioIntelliSense, Inc