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

September 2, 2021 updated by: Elie F. Berbari, Mayo Clinic

Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India
        • Sri Jayadeva
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • King Edward Memorial Hospital
  • Spain
      • Madrid, Spain
        • Gregorio Marañón Hospital
  • United Kingdom
    • England
      • London, England, United Kingdom
        • Imperial College
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSUHSC Shreveport
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Detection of COVID-19 when compared to a PCR test in asymptomatic patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID 19 Detection
Time Frame: 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.
One time screening within 4 hours of PCR test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Actual)

June 3, 2021

Study Completion (Actual)

June 3, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-011415

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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