Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
- Registration Number
- NCT04351763
- Lead Sponsor
- Nicolaus Copernicus University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 804
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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amiodarone Amiodarone 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 Verapamil 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.
- Primary Outcome Measures
Name Time Method Clinical improvement Randomization to day 15 Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
- Secondary Outcome Measures
Name Time Method Clinical improvement Randomization to day 7 and 28 Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
Cardiac troponins 7, 10 and 15 days after randomization assessed serially
Mortality Randomization to day 28 Individual endpoint
Time to resolution of fever Randomization to day 28 Defined as body temperature (≤36.6°C \[axilla\], or ≤37.2 °C \[oral\], or ≤37.8°C \[rectal\]) for at least 48 hours without antipyretics or until discharge, whichever is sooner.
Tachyarrhythmias Randomization to day 28 defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment
Time to clinical improvement from admission using the 7-point ordinal scale Randomization to day 28 Clinical improvement assessed on a seven category scale ranging from 1 to 7.
Change in NEWS2 score Randomization to day 7 and 15 The National Early Warning Score (NEWS2) score. A Higher score is worse.
Duration of hospitalization Randomization to day 28 Length of hospitalization in days
PO2/FIO2 Randomization to day 7 and 15 oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2)
Trial Locations
- Locations (1)
Nicolaus Copernicus University
🇵🇱Bydgoszcz, Poland