Pirfenidone Treatment to Prevent Lung Fibrosis in Adults With Acute Respiratory Distress Syndrome ARDS

What this Trial Is About

Acute respiratory distress syndrome ARDS is a serious lung condition causing inflammation and fluid buildup, leading to severe breathing problems and high mortality in intensive care units worldwide. Despite many clinical trials, no specific drug has yet proven effective in treating ARDS. The study aims to evaluate the anti-fibrotic medication Pirfenidone, previously used for idiopathic pulmonary fibrosis, to see if it can prevent lung fibrosis and improve outcomes in ARDS patients. Participants will be randomly assigned to receive either Pirfenidone or a placebo. Pirfenidone dosing starts at 801 mg per day for the first week, increases to 1602 mg per day for the second week, and then to 2403 mg per day until ICU discharge. The medication or placebo is given through a nasogastric tube in three divided doses daily. This is a phase 3 randomized controlled trial conducted across multiple centers. Throughout the study, researchers will monitor the number of days participants are free from ventilators within 28 days, length of ICU stay, lung imaging changes, mortality rates, lung function tests, heart function, and quality of life up to one year. Samples from the lungs will also be collected to study inflammation. Safety and any adverse effects will be closely tracked. The study will continue until December 2026.

Pirfenidone to Prevent Fibrosis in Ards.