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Pirfenidone to Prevent Fibrosis in Ards.

Pirfenidone · Phase 3

Registry ID
NCT05075161
Phase
Phase 3
Status
Recruiting
Drug / intervention
Pirfenidone
Sponsor
Università Vita-Salute San Raffaele
Start
2022-06-01
Enrollment
130
Locations
17

About this trial

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.

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Medical disclaimer. This page summarizes public trial data for NCT05075161 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.