Covid19Phase 2/3FaST-1NCT04588792
Furosemide as Supportive Therapy for COVID-19 Respiratory Failure
A Phase 2/3 study testing Nebulized Furosemide and Nebulized Saline in people with Covid19 and Respiratory Failure, run by Dr. John Muscedere at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Covid19, Respiratory Failure
- What is being tested?
- Nebulized Furosemide and Nebulized Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesCanada
- Study dates
- 16 Apr 2021to 30 Apr 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Alberta
Edmonton, Alberta
Dalhousie University
Halifax, Nova Scotia
Kingston Health Sciences Center
Kingston, Ontario, K7L2V7
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
About this study
Official title: Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19 - A Phase 2/3 Study
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.
Read the detailed description
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. The primary objective of the study is to establish the efficacy and safety of nebulized furosemide for the treatment of respiratory failure secondary to COVID-19 infection requiring invasive mechanical ventilation. The secondary objective is to delineate the anti-inflammatory properties of furosemide in COVID- 19 patients using pharmacokinetic / pharmacodynamic analysis. The duration of the intervention will be up to 28 days of intervention and patients will be followed till 60 days post randomization. Participants will be randomized to either: Intervention Group: 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 OR Control Group: placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily for up to 28 days. One hundred and forty-four (144) evaluable patients will be enrolled in the Phase 2 study. If evidence of efficacy is found in the Phase 2 portion, these patients will be enrolled in the Phase 3 study which aims to recruit 640 patients total (496 additional patients to the phase 2 patients).
- Conditions
- Covid19, Respiratory Failure
- Being tested
- Nebulized Furosemide, Nebulized Saline
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized FurosemideDrug
Furosemide administered by nebulization through the ventilator circuit
Nebulized SalineDrug
Saline administered by nebulization through the ventilator circuit
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Nebulized Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pulmonary gas exchange
Improvement in oxygenation as determined by a standardized PaO2/FiO2 ratio
Measured: Study Day 6
Requirement for mechanical ventilation
Number of ventilator-free days in the first 28 days after enrollment
Measured: Baseline to day 28
Secondary outcomes (6)
Mortality
All Cause
Measured: Day 60 post enrollment
Requirement for supplemental oxygen
Number of days of alive and not requiring supplemental oxygen
Measured: To day 28 post enrollment
Duration of ICU Stay
Duration of ICU Stay
Measured: Up to 60 days post enrollment
Length of hospitalization
Length of hospitalization
Measured: Up to 60 days post enrollment
Adverse events
Incidence of serious adverse events: incorporated as trial outcomes, defined a priori, in accordance with guidelines for academic ICU drug trials
Measured: Up to 60 days post enrollment
Inhalation adverse events
Adverse events during the nebulization of furosemide
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start16 Apr 2021
- Primary completion1 Feb 2023
- Study completion30 Apr 2023
Why it stopped: Lack of recruitment due to decline in critically ill Covid-19 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. John Muscedere
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor-investigator, Dr. John Muscedere, Queen's University
- Investigators
- John Muscedere, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588792
- Sponsor's protocol ID
- FaST-1
- Acronym
- FaST-1
- Status last verified
- Dec 2023
- First submitted
- 14 Oct 2020
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32622469Wang 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.
PubMed 32704455
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Furosemide for Pulmonary Inflammation in Intubated Patients With COVID-19 - A Phase 2/3 Study
- ClinicalTrials.gov ID
- NCT04588792
- Acronym / sponsor ID
- FaST-1 / FaST-1
- Conditions
- Covid19, Respiratory Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment due to decline in critically ill Covid-19 patients
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. John MuscedereUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The primary objective of the study is to establish the efficacy and safety of nebulized furosemide for the treatment of respiratory failure secondary to COVID-19 infection requiring invasive mechanical ventilation. The secondary objective is to delineate the anti-inflammatory properties of furosemide in COVID- 19 patients using pharmacokinetic / pharmacodynamic analysis. The duration of the intervention will be up to 28 days of intervention and patients will be followed till 60 days post randomization. Participants will be randomized to either: Intervention Group: 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 OR Control Group: placebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily for up to 28 days. One hundred and forty-four (144) evaluable patients will be enrolled in the Phase 2 study. If evidence of efficacy is found in the Phase 2 portion, these patients will be enrolled in the Phase 3 study which aims to recruit 640 patients total (496 additional patients to the phase 2 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Furosemide | Experimental | Drug: Nebulized Furosemide40 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 |
| Nebulized Saline | Placebo comparator | Drug: Nebulized SalinePlacebo, given by nebulization (4 mL of 0.9% saline solution) over 30 mins four times daily (Q.I.D.) for up to 28 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized FurosemideFurosemide administered by nebulization through the ventilator circuit | Drug | Inhaled Furosemide |
| Nebulized SalineSaline administered by nebulization through the ventilator circuit | Drug | Nebulized Saline |
Primary outcome
Improvement in pulmonary gas exchange
Time frame: Study Day 6
Improvement in oxygenation as determined by a standardized PaO2/FiO2 ratio
Requirement for mechanical ventilation
Time frame: Baseline to day 28
Number of ventilator-free days in the first 28 days after enrollment
6 secondary outcomes
Mortality
Time frame: Day 60 post enrollment
Requirement for supplemental oxygen
Time frame: To day 28 post enrollment
Duration of ICU Stay
Time frame: Up to 60 days post enrollment
Length of hospitalization
Time frame: Up to 60 days post enrollment
Adverse events
Time frame: Up to 60 days post enrollment
Inhalation adverse events
Time frame: Up to day 28
Results and safety
The study was stopped early (reason given: Lack of recruitment due to decline in critically ill Covid-19 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 32622469Brennecke 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.
- Background: PubMed 32704455Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Muscedere, MD principal investigator
Queens University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nebulized Furosemide and Nebulized Saline in people with Covid19 and Respiratory Failure, run by Dr. John Muscedere at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment due to decline in critically ill Covid-19 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pulmonary gas exchange (time frame: Study Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.