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Completed

NCT Number: NCT04371744

QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19

This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years old
  • SARS-COV-2 confirmed infection by positive nasopharyngual PCR
  • Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy
  • Patient's smartphone able to download the smartwatches application

Exclusion criteria

  • Presence of a pacemaker
  • Pregnant or breastfeeding females
  • Refusal to participate
  • Incapacity
  • Adult under legal protection (trusteeship, guardianship)

Treatment and study plan

Primary outcomes

  1. Corrected QT (QTc) interval measurement

    Time frame: 10 days

    Measurement of QTc using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches, compare to standard 12 leads ECG reviewed by cardiologist

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

QT-Logs : a Clinical Study to Monitor Cardiac Safety, With Artificial Intelligence for QT Interval Analysis of ECG Data From Smartwatches, in Patients Receiving Hydroxychloroquine Treatment for COVID-19

Acronym: QT-Logs

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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