Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

COVID-19 Clinical Trial

— ReCOVery-SIRIO  

Official title:

Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351763
• Other study ID #: NCU-COVID19
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2020
• Est. completion date: June 5, 2021

Study information

• Verified date: August 2021
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: June 5, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Amiodarone
Ion channel blocker
• Verapamil
Ion channel blocker

Locations

Country	Name	City	State
Poland	Nicolaus Copernicus University	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Time to first occurrence of clinical improvement assessed on a seven category scale ranging from 1 to 7	Randomization to day 15
Secondary	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
Secondary	Cardiac troponins	assessed serially	7, 10 and 15 days after randomization
Secondary	Mortality	Individual endpoint	Randomization to day 28
Secondary	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
Secondary	Tachyarrhythmias	defined as atrial fibrillation, supraventricular or ventricular tachycardia requiring treatment	Randomization to day 28
Secondary	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
Secondary	Change in NEWS2 score	The National Early Warning Score (NEWS2) score. A Higher score is worse.	Randomization to day 7 and 15
Secondary	Duration of hospitalization	Length of hospitalization in days	Randomization to day 28
Secondary	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