Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms (ReCOVery-SIRIO)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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)
Sites / Locations
- Nicolaus Copernicus University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Amiodarone
Verapamil
Usual Care
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.
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.