Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms (ReCOVery-SIRIO)
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|ClinicalTrials.gov Identifier: NCT04351763|
Recruitment Status : Completed
First Posted : April 17, 2020
Last Update Posted : September 5, 2021
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Amiodarone Drug: Verapamil||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||804 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||parallel group, randomized trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.|
|Official Title:||Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms|
|Actual Study Start Date :||May 20, 2020|
|Actual Primary Completion Date :||May 25, 2021|
|Actual Study Completion Date :||June 5, 2021|
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.
200 to 400 mg/day (adjust dosage based on cardiac response and age) up to discharge.
Ion channel blocker
Verapamil - administered intravenously
Bolus of 0.075-0.15 mg/kg (5-10 mg) over at least 3 minutes, then switch to 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.
Ion channel blocker
|No Intervention: Usual Care|
- Clinical improvement [ Time Frame: Randomization to day 15 ]Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
- Clinical improvement [ Time Frame: 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 [ Time Frame: 7, 10 and 15 days after randomization ]assessed serially
- Mortality [ Time Frame: Randomization to day 28 ]Individual endpoint
- Time to resolution of fever [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Randomization to day 28 ]Clinical improvement assessed on a seven category scale ranging from 1 to 7.
- Change in NEWS2 score [ Time Frame: Randomization to day 7 and 15 ]The National Early Warning Score (NEWS2) score. A Higher score is worse.
- Duration of hospitalization [ Time Frame: Randomization to day 28 ]Length of hospitalization in days
- PO2/FIO2 [ Time Frame: 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)
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351763
|Nicolaus Copernicus University|
|Responsible Party:||Eliano Pio Navarese, Prof Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University|
|Other Study ID Numbers:||
|First Posted:||April 17, 2020 Key Record Dates|
|Last Update Posted:||September 5, 2021|
|Last Verified:||August 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs