NCT04437901

COVIDAR - Arrhythmias in COVID-19

COVIDAR - International Registry on Arrhythmias in COVID-19

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2020-06-18
• Last updated: 2020-06-18

Locations

5 sites across 5 countries: Belgium, Italy, Netherlands, Spain, United Kingdom