Clinical trial NCT04437901: COVIDAR - Arrhythmias in COVID-19
Official title: COVIDAR - International Registry on Arrhythmias in COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Arrhythmia
Torsades de Pointe Caused by Drug
Qt Interval, Variation in
Atrioventricular Block
Atrial Fibrillation
Bradyarrhythmia
Ventricular Arrythmia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Istituto Auxologico Italiano
name: St George's University Hospitals NHS Foundation Trust
name: University Hospital, Antwerp
name: European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART)
name: European Society of Cardiology
First posted: 2020-06-18
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Formal opposition by the patient to data collection.

Primary outcomes:
measure: Arrhythmia
timeFrame: 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 outcomes:
measure: Electrocardiographic changes - Underlying rhythm
timeFrame: 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
measure: Electrocardiographic changes - Atrioventricular conduction
timeFrame: 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
measure: Electrocardiographic changes - QRS duration
timeFrame: 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
measure: Electrocardiographic changes - presence of Brugada QRS pattern
timeFrame: 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
measure: Electrocardiographic changes - QTc duration
timeFrame: 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
measure: Laboratory abnormalities - electrolyte misbalance
timeFrame: 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
measure: Laboratory abnormalities - cardiac biomarkers
timeFrame: 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
measure: Laboratory abnormalities - renal function
timeFrame: 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
measure: Laboratory abnormalities - liver function
timeFrame: 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
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Antwerp University Hospital
city: Milan
country: Italy
facility: Istituto Auxologico Italiano, IRCCS
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: AZ
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: London
country: United Kingdom
facility: St. Georges University Hospitals
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Elena Arbelo, MD, PhD, MSc
role: STUDY_CHAIR
affiliation: Amsterdam UMC
name: Arthur A Wilde, MD, PhD
role: STUDY_DIRECTOR
affiliation: Istituto Auxologico Italiano, IRCCS
name: Lia Crotti, MD, PhD
role: STUDY_DIRECTOR
affiliation: St George's University Hospitals NHS Foundation Trust
name: Elijah Behr, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Antwerp
name: Hein Heidbuchel, MD, PhD
role: STUDY_DIRECTOR
References: