COVID-19
Conditions
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.
Interventions
DRUGAmiodarone
Ion channel blocker
DRUGVerapamil
Ion channel blocker
Sponsors
Nicolaus Copernicus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.
Intervention model description
parallel group, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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. |
Countries
Poland
Outcome results
None listed