Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2021-06-05

Brief Summary

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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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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel group, randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

Amiodarone

Intervention Type DRUG

Ion channel blocker

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.

Group Type EXPERIMENTAL

Verapamil

Intervention Type DRUG

Ion channel blocker

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amiodarone

Ion channel blocker

Intervention Type DRUG

Verapamil

Ion channel blocker

Intervention Type DRUG

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No