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NCT Number: NCT04351763

Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nicolaus Copernicus University

Bydgoszcz, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Amiodarone

Drug

Ion channel blocker

Verapamil

Drug

Ion channel blocker

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Cardiac troponins

    Time frame: 7, 10 and 15 days after randomization

    assessed serially

  3. Mortality

    Time frame: Randomization to day 28

    Individual endpoint

  4. 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.

  5. Tachyarrhythmias

    Time frame: Randomization to day 28

    defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment

  6. 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.

  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.

  8. Duration of hospitalization

    Time frame: Randomization to day 28

    Length of hospitalization in days

  9. 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)

Sponsors and collaborators

Lead sponsor

Nicolaus Copernicus University

Other

Registry information

Acronym: ReCOVery-SIRIO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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