Pirfenidone to Prevent Fibrosis in Ards.
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Acute Respiratory Distress Syndrome (ARDS)
In brief
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. Fibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution. Pirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models. This is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.
Key facts
- Study ID
- NCT05075161
- Run by
- Università Vita-Salute San Raffaele
- People needed
- 130
- Starts
- 2022-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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
You may not qualify 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
- 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)
Where it is running
- IRCCS San Raffaele Scientific Institute — Milan, MI, Italy (enrolling)
- Ospedale Cesare Arrigo — Alessandria, Piedmont, Italy (enrolling)
- Ospedale Santa Maria — Bari, Italy (enrolling)
- ASST Spedali Civili di Brescia — Brescia, Italy (enrolling)
- Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari — Cagliari, Italy (enrolling)
- Ospedale di Merano — Merano, Italy (enrolling)
- Ospedale Uboldo di Cernusco sul Naviglio — Milan, Italy (enrolling)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
- AOU Policlinico Paolo Giaccone — Palermo, Italy (enrolling)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (enrolling)
- AOU Pisana — Pisa, Italy (enrolling)
- A.O.R San Carlo — Potenza, Italy (enrolling)
- Fondazione PTV - Policlinico Tor Vergata — Rome, Italy (enrolling)
- Azienda Ospedaliero Universitaria Senese — Siena, Italy (enrolling)
- AOU Città della Salute e della Scienza — Torino, Italy (enrolling)
- Azienda Sanitaria Universitaria Integrata di Udine — Udine, Italy (enrolling)
- Astana Medical University — Astana, Kazakhstan (enrolling)
Full record on ClinicalTrials.gov
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