Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19

SARS-CoV-2 Infection Clinical Trial

— RYTHMO-COV  

Official title:

Study of Arrhythmia and ECG Abnormalities in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937621
• Other study ID #: CHUBX 2020/18
• Status: Completed
• Start date: June 2, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 31, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Minor,
• Inability to understand the study

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• ECG data analysis
Baseline ECG as well as follow-up ECG are analysed

Drug:
• Treatment data collect
Baseline treatment data as well as follow-up treatment data are collected

Biological:
• Biological check-up data collect
Baseline Biological check-up data as well as follow-up data are collected

Other:
• Collection of clinical events of interest
Clinical events of interest at the baseline as well as follow-up clinical events are collected

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of ECGs abnormalities in patients SARS-CoV-2 infection	Percentage of ECGs with abnormalities	Day 0
Secondary	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	Baseline and 1 month
Secondary	Rate of syncope during treatment	The number of syncope is measured during the treatment	Baseline and 1 month
Secondary	Rate of cardiac death during treatment	The number of cardiac death is measured during the treatment	Baseline and 1 month
Secondary	Rate of arrhythmia during treatment	The number of arrhythmia is measured during the treatment	Baseline and 1 month