Pirfenidone to Prevent Fibrosis in Ards.
Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Pirfenidone
From days 1-7: 801mg/day; from days 8-14:1602mg/day, from day 15 to ICU discharge 2403 mg/day. All drugs will be delivered by a nasogastric tube divided in 3 daily doses.
Placebo
All drugs will be delivered by a nasogastric tube divided in 3 daily doses.