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Study identifier: NCT05075161 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pirfenidone to Prevent Fibrosis in Ards.

Condition: Acute Respiratory Distress Syndrome (ARDS)  ·  Sponsor: Università Vita-Salute San Raffaele

PhasePhase 3
Planned participants130
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nora Di Tomasso, MD  ·  +39022643  ·  ditomasso.nora@hsr.it

Giacomo Monti, MD  ·  +39022643  ·  monti.giacomo@hsr.it

Always discuss trial participation with your own doctor first.

Locations (17)

IRCCS San Raffaele Scientific InstituteMilan, MI, ItalyRecruiting
Ospedale Cesare ArrigoAlessandria, Piedmont, ItalyRecruiting
Ospedale Santa MariaBari, ItalyRecruiting
ASST Spedali Civili di BresciaBrescia, ItalyRecruiting
Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di CagliariCagliari, ItalyRecruiting
Ospedale di MeranoMerano, ItalyRecruiting
Ospedale Uboldo di Cernusco sul NaviglioMilan, ItalyRecruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilan, ItalyRecruiting
AOU Policlinico Paolo GiacconePalermo, ItalyRecruiting
Azienda Ospedaliero Universitaria PisanaPisa, ItalyRecruiting
AOU PisanaPisa, ItalyRecruiting
A.O.R San CarloPotenza, ItalyRecruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05075161