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

Terminated

• Conditions: Covid19

• Registration Number: NCT04725097
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Primary Completion: 2021-06-03
• Study Completion: 2021-06-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2821

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).

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Exclusion Criteria

• Unwilling or unable to provide informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Henry Ford Health System; 🇺🇸 West Bloomfield, Michigan, United States

Hackensack Meridian Health; 🇺🇸 Hackensack, New Jersey, United States

LSUHSC Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Gregorio Marañon Hospital; 🇪🇸 Madrid, Spain

Sri Jayadeva; 🇮🇳 Bengaluru, Karnataka, India

King Edward Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India

Imperial College; 🇬🇧 London, England, United Kingdom

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States