COVID-19QT-LogsNCT04371744
QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19
An observational study of COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2020to 5 Jun 2020
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 consecutives patients ambulatory treated with the Hydroxychloroquine and Azythromycine combination, at the early stage of COVID-19 infection for 10 days, at the university hospital of La Timone, in Marseille
Who may be able to join
- 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
Who cannot join
- Presence of a pacemaker
- Pregnant or breastfeeding females
- Refusal to participate
- Incapacity
- Adult under legal protection (trusteeship, guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start17 Apr 2020
- Primary completion4 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371744
- Sponsor's protocol ID
- CIL 2020-52
- Acronym
- QT-Logs
- Status last verified
- Jun 2020
- First submitted
- 30 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maille B, Wilkin M, Million M, Resseguier N, Franceschi F, Koutbi-Franceschi L, Hourdain J, Martinez E, Zabern M, Gardella C, Tissot-Dupont H, Singh JP, Deharo JC, Fiorina L. Smartwatch Electrocardiogram and Artificial Intelligence for Assessing Cardiac-Rhythm Safety of Drug Therapy in the COVID-19 Pandemic. The QT-logs study. Int J Cardiol. 2021 May 15;331:333-339. doi: 10.1016/j.ijcard.2021.01.002. Epub 2021 Jan 29.
PubMed 33524462
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04371744
- Acronym / sponsor ID
- QT-Logs / CIL 2020-52
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutives patients ambulatory treated with the Hydroxychloroquine and Azythromycine combination, at the early stage of COVID-19 infection for 10 days, at the university hospital of La Timone, in Marseille
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Presence of a pacemaker
- Pregnant or breastfeeding females
- Refusal to participate
- Incapacity
- Adult under legal protection (trusteeship, guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 33524462Maille B, Wilkin M, Million M, Resseguier N, Franceschi F, Koutbi-Franceschi L, Hourdain J, Martinez E, Zabern M, Gardella C, Tissot-Dupont H, Singh JP, Deharo JC, Fiorina L. Smartwatch Electrocardiogram and Artificial Intelligence for Assessing Cardiac-Rhythm Safety of Drug Therapy in the COVID-19 Pandemic. The QT-logs study. Int J Cardiol. 2021 May 15;331:333-339. doi: 10.1016/j.ijcard.2021.01.002. Epub 2021 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected QT (QTc) interval measurement (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.