Status:
COMPLETED
Wearable Diagnostic for Detection of COVID-19 Infection
Lead Sponsor:
ClinOne, Inc.
Collaborating Sponsors:
BioIntelliSense, Inc
Phillips North America, LLC
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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 infectio...
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 eval...
Eligibility Criteria
Inclusion
- Cohort 1- Exposed/ Early Symptomatic Group
- age 18 or older;
- able to follow the study device wear instructions per the Instructions for Use;
- no positive viral test within 60 days prior to enrollment; and
- willing and able to provide written, informed consent.
Exclusion
- pregnant or breastfeeding;
- wearing a defibrillator or pacemaker;
- known or suspected cardiac dysrhythmias
- known or suspected allergy to adhesives;
- chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
- open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper chest preventing placement of the biosensor; and
- 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:
- Age 18 or older; 12 years of age -17 years of age are approved to participate in the vaccine Cohort portion of the study.
- scheduled to receive their first and second dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine
- able to follow the study device wear instructions per the Instructions for Use;
- no positive viral test within 60 days prior to enrollment; and
- willing and able to provide written, informed consent.
- Willing and able to take an oral temperature
Key Trial Info
Start Date :
December 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 15 2022
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT04742569
Start Date
December 21 2020
End Date
January 15 2022
Last Update
January 20 2022
Active Locations (1)
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1
ClinOne, Inc
Greenwood Village, Colorado, United States, 80111