Wearable Diagnostic for Detection of COVID-19 Infection

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.

Eligibility Criteria:
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