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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04437901
Other study ID # HCB/2020/0333
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2020
Est. completion date December 2021

Study information

Verified date June 2020
Source Hospital Clinic of Barcelona
Contact Elena Arbelo, MD, PhD
Phone +34 93 227 5551
Email EARBELO@clinic.cat
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Formal opposition by the patient to data collection.

Study Design


Locations

Country Name City State
Belgium Antwerp University Hospital Antwerpen
Italy Istituto Auxologico Italiano, IRCCS Milan
Netherlands Amsterdam UMC Amsterdam AZ
Spain Hospital Clinic of Barcelona Barcelona
United Kingdom St. Georges University Hospitals London

Sponsors (7)

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

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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