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

Overview

About this study

The purpose of this study is to determine the safety and feasibility of the POC AI-ECG’s ability to detect active SARS-Cov-2 infection in humans, and to determine specificity, sensitivity, and diagnostic accuracy of POC AI-ECG’s detection of human with COVID-19 when compared to a PCR test in asymptomatic patients.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elie Berbari, M.D.

Open for enrollment

Contact information:

Jennifer Dugan

Dugan.Jennifer@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Elie Berbari, M.D.

Contact us for the latest status

Contact information:

Jennifer Dugan

Dugan.Jennifer@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elie Berbari, M.D.

Contact us for the latest status

Contact information:

Jennifer Dugan

Dugan.Jennifer@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20506028

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