Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms (ReCOVery-SIRIO)

Nicolaus Copernicus University

Status and phase: Completed; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Amiodarone; Drug: Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT04351763

NCU-COVID19

Details and patient eligibility

About

There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.

Enrollment: 804 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) > 200.

Exclusion criteria

• Acute respiratory distress syndrome (ARDS)
• Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
• Long QT syndrome
• Prolonged baseline QTc interval (≥450 ms).
• Cardiogenic shock or severe hypotension (SBP< 90 mmHg)
• Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
• Severe sinus - node dysfunction with marked sinus bradycardia
• 2nd/3rd degree heart block
• Bradycardia without pacemaker that has caused syncope
• History of severe dysthyroidism
• A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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804 participants in 3 patient groups

Amiodarone

Experimental group

Description:

Amiodarone - administered intravenously Bolus of 150 mg is given over a minimum of 10 min, with subsequent continuous infusion of 1 mg/min for 6 h, next continuous infusion of 0.5 mg/min for 18 h, then switch to oral administration. Oral administration 200 to 400 mg/day (adjust dosage based on cardiac response and age) up to discharge.

Treatment:

Drug: Amiodarone

Verapamil

Experimental group

Description:

Verapamil - administered intravenously Bolus of 0.075-0.15 mg/kg (5-10 mg) over at least 3 minutes, then switch to oral administration. Oral administration 120 to 480 mg/day in divided doses every 6-8 hours (adjust dosage based on cardiac response and age) up to discharge.

Treatment:

Drug: Verapamil

Usual Care

No Intervention group