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Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms (ReCOVery-SIRIO)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Amiodarone
Verapamil
Sponsored by
Nicolaus Copernicus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nicolaus Copernicus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Amiodarone

Verapamil

Usual Care

Arm Description

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 - 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical improvement
Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7
Cardiac troponins
assessed serially
Mortality
Individual endpoint
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.
Tachyarrhythmias
defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment
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.
Change in NEWS2 score
The National Early Warning Score (NEWS2) score. A Higher score is worse.
Duration of hospitalization
Length of hospitalization in days
PO2/FIO2
oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2)

Full Information

First Posted
April 14, 2020
Last Updated
August 30, 2021
Sponsor
Nicolaus Copernicus University
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1. Study Identification

Unique Protocol Identification Number
NCT04351763
Brief Title
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Acronym
ReCOVery-SIRIO
Official Title
Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
June 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicolaus Copernicus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
parallel group, randomized trial
Masking
Outcomes Assessor
Masking Description
Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amiodarone
Arm Type
Experimental
Arm Description
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.
Arm Title
Verapamil
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
Ion channel blocker
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
Ion channel blocker
Primary Outcome Measure Information:
Title
Clinical improvement
Description
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 Outcome Measure Information:
Title
Clinical improvement
Description
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
Title
Cardiac troponins
Description
assessed serially
Time Frame
7, 10 and 15 days after randomization
Title
Mortality
Description
Individual endpoint
Time Frame
Randomization to day 28
Title
Time to resolution of fever
Description
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
Title
Tachyarrhythmias
Description
defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment
Time Frame
Randomization to day 28
Title
Time to clinical improvement from admission using the 7-point ordinal scale
Description
Clinical improvement assessed on a seven category scale ranging from 1 to 7.
Time Frame
Randomization to day 28
Title
Change in NEWS2 score
Description
The National Early Warning Score (NEWS2) score. A Higher score is worse.
Time Frame
Randomization to day 7 and 15
Title
Duration of hospitalization
Description
Length of hospitalization in days
Time Frame
Randomization to day 28
Title
PO2/FIO2
Description
oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2)
Time Frame
Randomization to day 7 and 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Nicolaus Copernicus University
City
Bydgoszcz
Country
Poland

12. IPD Sharing Statement

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Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

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