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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone | Experimental | 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 | Experimental | 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. |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug | Ion channel blocker |
| |
| Verapamil |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7 | Randomization to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7 | Randomization to day 7 and 28 |
| Cardiac troponins | assessed serially |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicolaus Copernicus University | Bydgoszcz | Poland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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parallel group, randomized trial
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Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.
| Drug |
Ion channel blocker |
|
| 7, 10 and 15 days after randomization |
| Mortality | Individual endpoint | Randomization to day 28 |
| Time to resolution of fever | 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. | Randomization to day 28 |
| Tachyarrhythmias | defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment | Randomization to day 28 |
| Time to clinical improvement from admission using the 7-point ordinal scale | Clinical improvement assessed on a seven category scale ranging from 1 to 7. | Randomization to day 28 |
| Change in NEWS2 score | The National Early Warning Score (NEWS2) score. A Higher score is worse. | Randomization to day 7 and 15 |
| Duration of hospitalization | Length of hospitalization in days | Randomization to day 28 |
| PO2/FIO2 | oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) | Randomization to day 7 and 15 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |