NCT04351763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started May 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 14, 2020

Last Update Submit

August 30, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Clinical improvement

    Randomization to day 7 and 28

  • Cardiac troponins

    7, 10 and 15 days after randomization

  • Mortality

    Randomization to day 28

  • Time to resolution of fever

    Randomization to day 28

  • Tachyarrhythmias

    Randomization to day 28

  • +4 more secondary outcomes

Study Arms (3)

Amiodarone

EXPERIMENTAL

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.

Drug: Amiodarone

Verapamil

EXPERIMENTAL

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.

Drug: Verapamil

Usual Care

NO INTERVENTION

Interventions

AmiodaroneDRUG

Ion channel blocker

Amiodarone
VerapamilDRUG

Ion channel blocker

Verapamil

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • nd/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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nicolaus Copernicus University

Bydgoszcz, Poland

Location

MeSH Terms

Conditions

COVID-19

Interventions

AmiodaroneVerapamil

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical events will be validated blindly by an independent clinical event committee (CEC) unaware of the treatment allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel group, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Eliano P. Navarese, MD, PhD

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 17, 2020

Study Start

May 20, 2020

Primary Completion

May 25, 2021

Study Completion

June 5, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

PL(1)