Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

• Status: Completed
• Trial end date: 2021-06-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicolaus Copernicus University
• Treatments: Amiodarone; Verapamil

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)