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Wearable Diagnostic for Detection of COVID-19 Infection

NCT04742569 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 790

Last updated 2022-01-20

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • BioIntelliSense, Inc

    collaborator UNKNOWN

  • Phillips North America, LLC

    collaborator UNKNOWN

  • University of Colorado, Denver

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • ClinOne, Inc.

    lead INDUSTRY

Principal Investigators

  • James Mault, MD · BioIntelliSense, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2022-01-15
Completion
2022-01-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742569 on ClinicalTrials.gov