Pirfenidone to Prevent Fibrosis in Ards.

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.

NCT Number	NCT05075161
Lead Sponsor	Università Vita-Salute San Raffaele
Conditions	Acute Respiratory Distress Syndrome (ARDS)
Enrollment	130 participants
Start Date	2022-06-01
Primary Completion	2026-06 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-08