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New treatment option for Acute Respiratory Distress Syndrome (ARDS)
Official title Pirfenidone to Prevent Fibrosis in Ards.
ClinicalTrials.gov ID: NCT05075161
What this study is testing
What is Pirfenidone?
Pirfenidone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute respiratory distress syndrome (ards).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Concomitant presence of:
- ARDS (moderate and severe) - Berlin definition
- Within 1 week of a known clinical insult or new or worsening respiratory symptoms
- Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
You likely can't join if
- Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\>7 days) up to the time of randomization
- ARDS severe or moderate for more than 36 hours
- Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF
- ARF fully explained by left ventricular failure or fluid overload
- Consent declined
- Severe chronic respiratory disease requiring domiciliary ventilation
See the full eligibility criteria
- Concomitant presence of:
- ARDS (moderate and severe) - Berlin definition
- Within 1 week of a known clinical insult or new or worsening respiratory symptoms
- Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- PaO2/FiO2\<200 mmHg with PEEP\<=5 cmH2O (invasive mechanical ventilation)
- Inflammatory ARDS phenotype (28), defined by at least one of the following:
- High plasma levels of inflammatory biomarkers
- Vasopressor dependence
- Lower serum bicarbonate or increased serum lactate
- Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.
- Age \>=18 years
- Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\>7 days) up to the time of randomization
- ARDS severe or moderate for more than 36 hours
- Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF
- ARF fully explained by left ventricular failure or fluid overload
- Consent declined
- Severe chronic respiratory disease requiring domiciliary ventilation
- Clinical suspicion for significant restrictive lung disease
- Pregnant women or women of childbearing potential who are sexually active
- Known allergy to pirfenidone
- Concomitant use of fluvoxamine
- Known severe hepatic failure
- Known severe renal failure or necessity of dialysis not related to acute disease
- Little chance of survival (SAPS II score\>75)
The study team makes the final eligibility decision.
Where it's taking place
- Milan, MI, Italy
- Alessandria, Piedmont, Italy
- Bari, Italy
- Brescia, Italy
- Cagliari, Italy
- Merano, Italy
- Milan, Italy
- Palermo, Italy
- Pisa, Italy
- Potenza, Italy
- Rome, Italy
- Siena, Italy
- Torino, Italy
- Udine, Italy
- Astana, Kazakhstan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, MI, Italy; Alessandria, Piedmont, Italy; Bari, Italy; Brescia, Italy; Cagliari, Italy; Merano, Italy and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.