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A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT04725097
Collaborator
(none)
2,821
Enrollment
10
Locations
5.7
Actual Duration (Months)
282.1
Patients Per Site
49.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2821 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study
    Actual Study Start Date :
    Dec 10, 2020
    Actual Primary Completion Date :
    Jun 3, 2021
    Actual Study Completion Date :
    Jun 3, 2021

    Outcome Measures

    Primary Outcome Measures

    1. COVID 19 Detection [One time screening within 4 hours of PCR test]

      Determine the safety and feasibility of the POC AI-ECG's ability to detect active SARS-Cov-2 infection in humans.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult males and females age 18 or greater.

    • Undergoing COVID-19 testing by PCR.

    • Willing and able to provide informed consent.

    • Pregnant females (minimal risk study, no risk from ECG).

    Exclusion Criteria:
    • Unwilling or unable to provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Phoenix Arizona United States 85054
    2 Mayo Clinic Jacksonville Florida United States 32224
    3 LSUHSC Shreveport Shreveport Louisiana United States 71103
    4 Henry Ford Health System West Bloomfield Michigan United States 48322
    5 Mayo Clinic Rochester Minnesota United States 55902
    6 Hackensack Meridian Health Hackensack New Jersey United States 07601
    7 Sri Jayadeva Bengaluru Karnataka India
    8 King Edward Memorial Hospital Mumbai Maharashtra India 400 012
    9 Gregorio Marañon Hospital Madrid Spain
    10 Imperial College London England United Kingdom

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Elie F Berbari, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Elie F. Berbari, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04725097
    Other Study ID Numbers:
    • 20-011415
    First Posted:
    Jan 26, 2021
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Sep 9, 2021