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

NCT ID: NCT04725097

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-06-03

Brief Summary

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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

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Elie F. Berbari

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elie F Berbari, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

LSUHSC Shreveport

Shreveport, Louisiana, United States

Site Status

Henry Ford Health System

West Bloomfield, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Hackensack Meridian Health

Hackensack, New Jersey, United States

Site Status

Sri Jayadeva

Bengaluru, Karnataka, India

Site Status

King Edward Memorial Hospital

Mumbai, Maharashtra, India

Site Status

Gregorio MaraƱon Hospital

Madrid, , Spain

Site Status

Imperial College

London, England, United Kingdom

Site Status

Countries

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United States India Spain United Kingdom

References

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Adedinsewo D, Dugan J, Johnson PW, Douglass EJ, Morales-Lara AC, Parkulo MA, Ting HH, Cooper LT, Scott LR, Valverde AM, Padmanabhan D, Peters NS, Bachtiger P, Kelshiker M, Fernandez-Aviles F, Atienza F, Glotzer TV, Lahiri MK, Dominic P, Attia ZI, Kapa S, Noseworthy PA, Pereira NL, Cruz J, Berbari EF, Carter RE, Friedman PA. RApid Throughput Screening for Asymptomatic COVID-19 Infection With an Electrocardiogram: A Prospective Observational Study. Mayo Clin Proc Digit Health. 2023 Sep 16;1(4):455-466. doi: 10.1016/j.mcpdig.2023.07.007. eCollection 2023 Dec.

Reference Type DERIVED
PMID: 40206301 (View on PubMed)

Related Links

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Other Identifiers

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20-011415

Identifier Type: -

Identifier Source: org_study_id

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