COVIDAR - Arrhythmias in COVID-19

NCT ID: NCT04437901

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID Arrhythmia Torsades de Pointe Caused by Drug Qt Interval, Variation in Atrioventricular Block Atrial Fibrillation Bradyarrhythmia Ventricular Arrythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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COVID-19 patients

Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Formal opposition by the patient to data collection.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART)

UNKNOWN

Sponsor Role collaborator

European Society of Cardiology

NETWORK

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Arbelo, MD, PhD, MSc

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Arthur A Wilde, MD, PhD

Role: STUDY_DIRECTOR

Amsterdam UMC

Lia Crotti, MD, PhD

Role: STUDY_DIRECTOR

Istituto Auxologico Italiano, IRCCS

Elijah Behr, MD, PhD

Role: STUDY_DIRECTOR

St George's University Hospitals NHS Foundation Trust

Hein Heidbuchel, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Antwerp

Locations

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Antwerp University Hospital

Antwerp, , Belgium

Site Status

Istituto Auxologico Italiano, IRCCS

Milan, , Italy

Site Status

Amsterdam UMC

Amsterdam, AZ, Netherlands

Site Status

Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status

St. Georges University Hospitals

London, , United Kingdom

Site Status

Countries

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Belgium Italy Netherlands Spain United Kingdom

Central Contacts

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Elena Arbelo, MD, PhD

Role: CONTACT

+34 93 227 5551

Facility Contacts

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Hein Heidbuchel, MD, PhD

Role: primary

Lia Crotti, MD, PhD

Role: primary

+39 02 6191 12374

Arthur A Wilde, MD, PhD

Role: primary

Elena Arbelo, MD, PhD, MSc

Role: primary

+34 93 227 5551

Elijah Behr, MD, PhD

Role: primary

+44 20 8725 4571

Other Identifiers

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HCB/2020/0333

Identifier Type: -

Identifier Source: org_study_id

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