COVIDAR - Arrhythmias in COVID-19 (COVIDAR)

June 17, 2020 updated by: Hospital Clinic of Barcelona

COVIDAR - International Registry on Arrhythmias in COVID-19

BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population.

MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection.

STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected.

STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.

Study Overview

Status

Unknown

Conditions

Detailed Description

The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.

The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.

The registry will include all patients and collect data at the following timepoints:

  • Admission: evaluation before SARS-CoV2 infection treatment initiation
  • On-treatment: evaluation 24-28h after treatment initiation
  • At any adverse event: evaluation if any adverse event occurs
  • At discharge: evaluation of clinical status at the end of the admission period.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Antwerp University Hospital
        • Contact:
        • Principal Investigator:
          • Hein Heidbuchel, MD, PhD
  • Italy
      • Milan, Italy, 20149
        • Istituto Auxologico Italiano, IRCCS
        • Contact:
        • Principal Investigator:
          • Lia Crotti, MD, PhD
  • Netherlands
    • AZ
      • Amsterdam, AZ, Netherlands, 1105 AZ
        • Amsterdam UMC
        • Contact:
        • Principal Investigator:
          • Arthur A Wilde, MD, PhD
        • Sub-Investigator:
          • Nynke Hoffman, MD, PhD
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
        • Contact:
        • Principal Investigator:
          • Elena Arbelo, MD, PhD, MSc
        • Sub-Investigator:
          • Marta Hernandez-Meneses, MD
        • Sub-Investigator:
          • Alex Soriano, MD, PhD
  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St. Georges University Hospitals
        • Contact:
        • Principal Investigator:
          • Elijah Behr, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.

Description

Inclusion Criteria:

  • Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.

Exclusion Criteria:

  • Formal opposition by the patient to data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COVID-19 patients
Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmia
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

Any arrhythmic event occurring in COVID-19 patients during hospital admission:

  • Monomorphic ventricular tachycardia
  • Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained)
  • Ventricular fibrillation
  • AV-block
  • Severe bradycardia, symptomatic and/or requiring treatment
  • New-onset atrial fibrillation
  • Other
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiographic changes - Underlying rhythm
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Categorical variable collecting the patient's underlying rhythm at baseline, on treatment and in case of arrhythmic adverse events): sinus rhythm, atrial fibrillation/flutter, other
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - Atrioventricular conduction
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Collected as a categorical (normal, 1st-, 2nd- or 3rd degree AV block) and a continuous (PR duration in ms) at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QRS duration
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - presence of Brugada QRS pattern
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Electrocardiographic changes - QTc duration
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - electrolyte misbalance
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Kalium, magnesium and calcium collected as continuous variables at baseline, on treatment and in case of arrhythmic adverse events). Will be reported as a categorical variable (presence/absence) of electrolyte misbalance
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - cardiac biomarkers
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Cardiac CK, troponin T and/or troponin I (where available) collected as a continuous variable at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - renal function
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Laboratory abnormalities - liver function
Time Frame: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

University Hospital, Antwerp
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Istituto Auxologico Italiano
St George's University Hospitals NHS Foundation Trust
European Society of Cardiology
European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART)

Investigators

  • Study Chair: Elena Arbelo, MD, PhD, MSc, Hospital Clinic of Barcelona
  • Study Director: Arthur A Wilde, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Study Director: Lia Crotti, MD, PhD, Istituto Auxologico Italiano, IRCCS
  • Study Director: Elijah Behr, MD, PhD, St George's University Hospitals NHS Foundation Trust
  • Study Director: Hein Heidbuchel, MD, PhD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/0333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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