COVIDAR - Arrhythmias in COVID-19

Study Overview
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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.

Official Title
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COVIDAR - International Registry on Arrhythmias in COVID-19

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

Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients<br>Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |