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NCT04371744 Clinical Trial

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

COVID-19 Clinical Trial

— QT-Logs  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04371744
Other study ID # CIL 2020-52
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date June 5, 2020

Study information
Verified date June 2020
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 5, 2020
Est. primary completion date June 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corrected QT (QTc) interval measurement 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 10 days
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