Clinical trial NCT04742569: Wearable Diagnostic for Detection of COVID-19 Infection
Official title: Wearable Diagnostic for Detection of COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Recent known exposure to COVID-19
Asymptomatic
Early COVID-19 Symptoms
Lead sponsor: ClinOne, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioIntelliSense, Inc
name: Phillips North America, LLC
name: University of Colorado, Denver
name: United States Department of Defense
First posted: 2021-02-08
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort 1- Exposed/Early Symptomatic Group All adult subjects seeking a COVID-19 test and meeting enrollment criteria will be offered enrollment into this study.

The Inclusion Criteria are:

1. Adults - 18 years of age and older
2. Both genders, all races and ethnic groups
3. English speaking adult subjects only

Cohort 2- Vaccine Group:

Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine

1. Subjects who are scheduled to receive the COVID vaccination series through local and national clinics, health systems and pharmacies.
2. Subjects who become aware of the study through public notices, postings, and advertisements, and other marketing efforts.

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
timeFrame: 14 days
measure: The primary outcome of interest are performance of the BioSticker, a medical grade multi-parameter wearable biosensor.
timeFrame: 14 days
measure: The primary outcome of interest are performance of the BioSticker wearable for detecting early onset of active COVID-19 related symptoms.
timeFrame: 14 days
measure: The primary outcome of interest is the sensitivity of the BioCloud-based algorithms in detecting early onset of active COVID-19.
timeFrame: 14 days
Secondary outcomes:
measure: The secondary outcomes of interest include correlation of biometric data indicators to patient reported symptoms.
timeFrame: 14 days
Other outcomes:
Locations:
city: Greenwood Village
country: United States
facility: ClinOne, Inc
state: Colorado
Study officials:
affiliation: BioIntelliSense, Inc
name: James Mault, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction-Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med. 2020 Aug 18;173(4):262-267. doi: 10.7326/M20-1495. Epub 2020 May 13.
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