Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

Nicolaus Copernicus University804 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

804

Conditions

COVID-19

Interventions

AmiodaroneDRUG

Ion channel blocker

VerapamilDRUG

Ion channel blocker

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (1)

Nicolaus Copernicus University

Bydgoszcz, Poland

Outcomes

Primary Outcomes

Clinical improvement

Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7

Time frame: Randomization to day 15

Secondary Outcomes

Clinical improvement

Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7

Time frame: Randomization to day 7 and 28

Cardiac troponins

assessed serially

Time frame: 7, 10 and 15 days after randomization

Mortality

Individual endpoint

Time frame: 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.

Time frame: Randomization to day 28

Tachyarrhythmias

defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment

Time frame: 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.

Time frame: Randomization to day 28

Change in NEWS2 score

The National Early Warning Score (NEWS2) score. A Higher score is worse.

Data from ClinicalTrials.gov

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