Wearable Diagnostic for Detection of COVID-19 Infection
Completed
Conditions studied: COVID-19
In brief
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.
Key facts
- Study ID
- NCT04742569
- Run by
- ClinOne, Inc.
- People needed
- 790
- Starts
- 2020-12-21
- Expected to finish
- 2022-01-15
- Last updated by the study team
- 2022-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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:
- 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.
Where it is running
- ClinOne, Inc — Greenwood Village, Colorado, United States
Full record on ClinicalTrials.gov
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