NCT04937621

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 22, 2021

Last Update Submit

June 22, 2021

Conditions

ArrhythmiaSARS-CoV-2 Infection

Keywords

COVID-19ECGTorsade de pointeQT interval

Outcome Measures

Primary Outcomes (1)

  • Proportion of ECGs abnormalities in patients SARS-CoV-2 infection

    Percentage of ECGs with abnormalities

    Day 0

Secondary Outcomes (4)

  • Evolution of PR, QRS and cQT interval

    Baseline and 1 month

  • Rate of syncope during treatment

    Baseline and 1 month

  • Rate of cardiac death during treatment

    Baseline and 1 month

  • Rate of arrhythmia during treatment

    Baseline and 1 month

Study Arms (1)

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.

Diagnostic Test: ECG data analysisDrug: Treatment data collectBiological: Biological check-up data collectOther: Collection of clinical events of interest

Interventions

ECG data analysisDIAGNOSTIC_TEST

Baseline ECG as well as follow-up ECG are analysed

SARS-CoV-2 infection
Treatment data collectDRUG

Baseline treatment data as well as follow-up treatment data are collected

SARS-CoV-2 infection
Biological check-up data collectBIOLOGICAL

Baseline Biological check-up data as well as follow-up data are collected

SARS-CoV-2 infection
Collection of clinical events of interestOTHER

Clinical events of interest at the baseline as well as follow-up clinical events are collected

SARS-CoV-2 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with SARS-CoV-2 infection followed by Bordeaux University Hospital for COVID-19

You may qualify if:

  • 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.

You may not qualify if:

  • Minor,
  • Inability to understand the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Arrhythmias, CardiacCOVID-19Torsades de Pointes

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTachycardia, VentricularTachycardiaCardiac Conduction System Disease

Study Officials

  • frédéric Sacher, MD-PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 24, 2021

Study Start

June 2, 2020

Primary Completion

December 2, 2020

Study Completion

December 31, 2020

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)