ArrhythmiaRYTHMO-COVNCT04937621
Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19
An observational study of Arrhythmia and SARS-CoV-2 Infection, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, SARS-CoV-2 Infection
- What is being tested?
- ECG data analysis, Treatment data collect and Biological check-up data collect
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 31 Dec 2020
- 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: All patients with SARS-CoV-2 infection followed by Bordeaux University Hospital for COVID-19
Who may be able to join
- Patients over 18 years of both gender,
- Followed by Bordeaux University Hospital for SARS-CoV-2 infection with a cardiac monitoring or ECG realized.
- Non opposition expressed.
Who cannot join
- Minor,
- Inability to understand the study
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de pointe. The investigators therefore create a study that include all patients with SARS-CoV-2 infection having an electrocardiogram (ECG). The investigators evaluate the percentage of patients with ECG abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected QT (cQT) interval modification in patients receiving treatment.
Read the detailed description
In patients with SARS-CoV-2 infection, the investigators analyze baseline ECG as well as follow-up ECG. Patients followed by Bordeaux University Hospital for COVID-19 can be included. ECG are digitized in the computerized patient file (DxCARE) for further analysis.
- Conditions
- Arrhythmia, SARS-CoV-2 Infection
- Being tested
- ECG data analysis, Treatment data collect, Biological check-up data collect, Collection of clinical events of interest
- Keywords
- COVID-19, ECG, Torsade de pointe, QT interval
- Medical subject headings
- Arrhythmias, Cardiac, COVID-19, Torsades de Pointes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG data analysisDiagnostic test
Baseline ECG as well as follow-up ECG are analysed
Treatment data collectDrug
Baseline treatment data as well as follow-up treatment data are collected
Biological check-up data collectBiological
Baseline Biological check-up data as well as follow-up data are collected
Collection of clinical events of interestOther
Clinical events of interest at the baseline as well as follow-up clinical events are collected
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 infection | This group includes patients prospectively included during their follow-up at the Bordeaux University Hospital for COVID-19, as well as retrospectively included patients whose follow-up for COVID-19 has been completed. Receives: Diagnostic Test: ECG data analysis; Drug: Treatment data collect; Biological: Biological check-up data collect; Other: Collection of clinical events of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ECGs abnormalities in patients SARS-CoV-2 infection
Percentage of ECGs with abnormalities
Measured: Day 0
Secondary outcomes (4)
Evolution of PR, QRS and cQT interval
The evolution of interval is measured in seconds for patients receiving drugs interfering with cardiac electrophysiology for SARS-CoV-2 infection
Measured: Baseline and 1 month
Rate of syncope during treatment
The number of syncope is measured during the treatment
Measured: Baseline and 1 month
Rate of cardiac death during treatment
The number of cardiac death is measured during the treatment
Measured: Baseline and 1 month
Rate of arrhythmia during treatment
The number of arrhythmia is measured during the treatment
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start2 Jun 2020
- Primary completion2 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- frédéric Sacher, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937621
- Sponsor's protocol ID
- CHUBX 2020/18
- Acronym
- RYTHMO-COV
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04937621
- Acronym / sponsor ID
- RYTHMO-COV / CHUBX 2020/18
- Conditions
- Arrhythmia, SARS-CoV-2 Infection
- Keywords
- COVID-19, ECG, Torsade de pointe, QT interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Jun 2021 (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.
Cardiac involvement has been described in Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection. Although there are no approved drugs to prevent or treat SARS-CoV-2 infection at present time, several medications used have the potential to increase QT interval and eventually provoke torsades de pointe. The investigators therefore create a study that include all patients with SARS-CoV-2 infection having an electrocardiogram (ECG). The investigators evaluate the percentage of patients with ECG abnormalities, describe the abnormalities and evaluate the occurrence of syncope, ventricular arrhythmia and corrected QT (cQT) interval modification in patients receiving treatment.
Detailed description
In patients with SARS-CoV-2 infection, the investigators analyze baseline ECG as well as follow-up ECG. Patients followed by Bordeaux University Hospital for COVID-19 can be included. ECG are digitized in the computerized patient file (DxCARE) for further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 infection | – | Diagnostic Test: ECG data analysis, Drug: Treatment data collect, Biological: Biological check-up data collect, Other: Collection of clinical events of interestThis group includes patients prospectively included during their follow-up at the Bordeaux University Hospital for COVID-19, as well as retrospectively included patients whose follow-up for COVID-19 has been completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with SARS-CoV-2 infection followed by Bordeaux University Hospital for COVID-19
Key inclusion criteria (3 listed)
- Patients over 18 years of both gender,
- Followed by Bordeaux University Hospital for SARS-CoV-2 infection with a cardiac monitoring or ECG realized.
- Non opposition expressed.
Key exclusion criteria (2 listed)
- Minor,
- Inability to understand the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG data analysisBaseline ECG as well as follow-up ECG are analysed | Diagnostic test | SARS-CoV-2 infection |
| Treatment data collectBaseline treatment data as well as follow-up treatment data are collected | Drug | SARS-CoV-2 infection |
| Biological check-up data collectBaseline Biological check-up data as well as follow-up data are collected | Biological | SARS-CoV-2 infection |
| Collection of clinical events of interestClinical events of interest at the baseline as well as follow-up clinical events are collected | Other | SARS-CoV-2 infection |
Primary outcome
Proportion of ECGs abnormalities in patients SARS-CoV-2 infection
Time frame: Day 0
Percentage of ECGs with abnormalities
4 secondary outcomes
Evolution of PR, QRS and cQT interval
Time frame: Baseline and 1 month
Rate of syncope during treatment
Time frame: Baseline and 1 month
Rate of cardiac death during treatment
Time frame: Baseline and 1 month
Rate of arrhythmia during treatment
Time frame: Baseline and 1 month
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 24 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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.
frédéric Sacher, MD-PhD principal investigator
University Hospital, Bordeaux
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 Arrhythmia and SARS-CoV-2 Infection, run by University Hospital, Bordeaux 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 3 inclusion and 2 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 24 Jun 2021. 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?
Proportion of ECGs abnormalities in patients SARS-CoV-2 infection (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2021.