Actively Recruiting
Pirfenidone to Prevent Fibrosis in Ards.
Led by Università Vita-Salute San Raffaele · Updated on 2026-05-08
130
Participants Needed
17
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pirfenidone to Prevent Fibrosis in Ards.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed moderate or severe ARDS according to Berlin definition within 1 week of clinical insult or worsening respiratory symptoms
- Bilateral lung opacities not explained by effusions, collapse, or nodules
- Respiratory failure not due to heart failure or fluid overload
- PaO2/FiO2 ratio less than 200 mmHg with PEEP less than or equal to 5 cmH2O while on invasive mechanical ventilation
- Presence of inflammatory ARDS phenotype defined by high inflammatory biomarkers, vasopressor dependence, or abnormal serum bicarbonate or lactate
- Informed consent given by patient, legal representative, or ethical committee
You will not qualify if you...
- Mechanical ventilation via endotracheal or tracheostomy tube for more than 7 days before randomization
- Moderate or severe ARDS lasting more than 36 hours
- Untreated pulmonary embolism, pleural effusion, or pneumothorax as cause of acute respiratory failure
- Respiratory failure fully explained by left ventricular failure or fluid overload
- Declined consent
- Severe chronic respiratory disease requiring home ventilation
- Suspected significant restrictive lung disease
- Pregnancy or sexually active women of childbearing potential
- Known allergy to Pirfenidone
- Current use of fluvoxamine
- Severe liver failure
- Severe kidney failure or dialysis not related to acute illness
- Very low chance of survival (SAPS II score greater than 75)
AI-Screening
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Trial Site Locations
Total: 17 locations
1
IRCCS San Raffaele Scientific Institute
Milan, MI, Italy, 20132
Actively Recruiting
2
Ospedale Cesare Arrigo
Alessandria, Piedmont, Italy, 15121
Actively Recruiting
3
Ospedale Santa Maria
Bari, Italy
Actively Recruiting
4
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
5
Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari
Cagliari, Italy, 09123
Actively Recruiting
6
Ospedale di Merano
Merano, Italy
Actively Recruiting
7
Ospedale Uboldo di Cernusco sul Naviglio
Milan, Italy, 20070
Actively Recruiting
8
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
9
AOU Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
10
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
11
AOU Pisana
Pisa, Italy
Actively Recruiting
12
A.O.R San Carlo
Potenza, Italy
Actively Recruiting
13
Fondazione PTV - Policlinico Tor Vergata
Rome, Italy, 00133
Actively Recruiting
14
Azienda Ospedaliero Universitaria Senese
Siena, Italy, 53100
Actively Recruiting
15
AOU Città della Salute e della Scienza
Torino, Italy, 10126
Actively Recruiting
16
Azienda Sanitaria Universitaria Integrata di Udine
Udine, Italy, 33100
Actively Recruiting
17
Astana Medical University
Astana, Kazakhstan, 010000
Actively Recruiting
Research Team
N
Nora Di Tomasso, MD
CONTACT
G
Giacomo Monti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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