NCT04588792

Brief Summary

This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

4 active sites

Status
terminated

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

October 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

October 14, 2020

Last Update Submit

December 4, 2023

Conditions

Covid19Respiratory Failure

Outcome Measures

Primary Outcomes (2)

  • Improvement in pulmonary gas exchange

    Improvement in oxygenation as determined by a standardized PaO2/FiO2 ratio

    Study Day 6

  • Requirement for mechanical ventilation

    Number of ventilator-free days in the first 28 days after enrollment

    Baseline to day 28

Secondary Outcomes (6)

  • Mortality

    Day 60 post enrollment

  • Requirement for supplemental oxygen

    To day 28 post enrollment

  • Duration of ICU Stay

    Up to 60 days post enrollment

  • Length of hospitalization

    Up to 60 days post enrollment

  • Adverse events

    Up to 60 days post enrollment

  • +1 more secondary outcomes

Other Outcomes (3)

  • Serum levels of furosemide

    Up to day 28

  • Electrolyte abnormalities

    Up to day 28

  • Cytokine levels

    Up to day 28

Study Arms (2)

Inhaled Furosemide

EXPERIMENTAL

40 mg furosemide per dose, given by nebulization (4 mL of 10 mg/mL furosemide in 0.9% saline solution) over 30 mins four times daily (Q6H) for up to 28 days

Drug: Nebulized Furosemide

Nebulized Saline

PLACEBO COMPARATOR

Placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily (Q.I.D.) for up to 28 days

Drug: Nebulized Saline

Interventions

Nebulized FurosemideDRUG

Furosemide administered by nebulization through the ventilator circuit

Inhaled Furosemide
Nebulized SalineDRUG

Saline administered by nebulization through the ventilator circuit

Nebulized Saline

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with respiratory failure secondary to COVID-19 (SARS-CoV-2) infection/pneumonia requiring invasive mechanical ventilation
  • Duration of mechanical ventilation less than 48 hours as measured from the time of randomization
  • If female, must not be pregnant at the time of enrollment as determined by a serum or urine pregnancy test

You may not qualify if:

  • Known history of severe chronic pulmonary disease (e.g., preinfection requirement for home oxygen therapy or presence of chronic hypercapnia (PaCO2\< 50 mm Hg); mild -moderate disease is still eligible in the absence of chronic hypercapnia or need for chronic oxygen therapy)
  • In the opinion of the PI, unlikely to survive for \>48 hours from time of enrollment
  • Enrollment in another trial of anti-inflammatory therapies for COVID-19.
  • Known allergy to furosemide or sulfonamide agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alberta

Edmonton, Alberta, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

Kingston Health Sciences Center

Kingston, Ontario, K7L2V7, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Related Publications (2)

  • Brennecke A, Villar L, Wang Z, Doyle LM, Meek A, Reed M, Barden C, Weaver DF. Is Inhaled Furosemide a Potential Therapeutic for COVID-19? Am J Med Sci. 2020 Sep;360(3):216-221. doi: 10.1016/j.amjms.2020.05.044. Epub 2020 Jun 1.

    PMID: 32622469BACKGROUND

  • Wang Z, Wang Y, Vilekar P, Yang SP, Gupta M, Oh MI, Meek A, Doyle L, Villar L, Brennecke A, Liyanage I, Reed M, Barden C, Weaver DF. Small molecule therapeutics for COVID-19: repurposing of inhaled furosemide. PeerJ. 2020 Jul 7;8:e9533. doi: 10.7717/peerj.9533. eCollection 2020.

    PMID: 32704455BACKGROUND

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Muscedere, MD

    Queens University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine, Queen's University

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 19, 2020

Study Start

April 16, 2021

Primary Completion

February 1, 2023

Study Completion

April 30, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)