biostudies-literatureBermudo-Peloche GCERCA ProgramRocheInstituto de Salud Carlos III2402249https://www.ebi.ac.uk/biostudies/studies/S-EPMC12018760biostudies-literatureUnknown65(4)<h4>Background</h4>Patients with severe COVID-19 may develop lung fibrosis. Pirfenidone is an anti-fibrotic drug approved for idiopathic pulmonary fibrosis. The efficacy and safety of pirfenidone in patients with fibrotic interstitial lung changes after recovery from severe COVID-19 pneumonia were evaluated.<h4>Methods</h4>This was a phase 2, double-blind, placebo-controlled, Spanish multicentre clinical trial. Patients were randomised to receive pirfenidone or placebo (2:1) for 24 weeks. The primary end-point was the proportion of patients that improved, considered when percentage change in forced vital capacity (FVC) was ≥10% and/or any reduction in the fibrotic score on chest high-resolution computed tomography (HRCT). Secondary end-points included health-related quality of life (HRQoL)The European respiratory journalPirfenidone in post-COVID-19 pulmonary fibrosis (FIBRO-COVID): a phase 2 randomised clinical trial.PMC12018760PI21/01287Santos-Perez SHereu PVicens-Zygmunt VBalcells EValenzuela CLopez Ramirez CFuentes MBlavia RMontes-Worboys ADel Rio BBadenes-Bonet DSellares JGutierrez-Rodriguez YCaballero PSanz-Santos JCaupena CCastillo DMolina-Molina MFerrer-Artola AFranquet TSegovia PBordas-Martinez JHernandez MPenafiel JBolivar SMillan-Billi PTomas LFernandez de Roitegi KGonzalez JLuburich PBermudo-Peloche GBadia MBPortillo KAlarcon JRodriguez-Portal JALaporta RRigual Bobillo JBarril SfalsePirfenidone in post-COVID-19 pulmonary fibrosis (FIBRO-COVID): a phase 2 randomised clinical trial.<h4>Background</h4>Patients with severe COVID-19 may develop lung fibrosis. Pirfenidone is an anti-fibrotic drug approved for idiopathic pulmonary fibrosis. The efficacy and safety of pirfenidone in patients with fibrotic interstitial lung changes after recovery from severe COVID-19 pneumonia were evaluated.<h4>Methods</h4>This was a phase 2, double-blind, placebo-controlled, Spanish multicentre clinical trial. Patients were randomised to receive pirfenidone or placebo (2:1) for 24 weeks. The primary end-point was the proportion of patients that improved, considered when percentage change in forced vital capacity (FVC) was ≥10% and/or any reduction in the fibrotic score on chest high-resolution computed tomography (HRCT). Secondary end-points included health-related quality of life (HRQoL)2025-01-01T00:00:00Z2025 Apr2026-07-15T05:42:52.577Z2026-07-01T03:07:06.218ZS-EPMC120187604015456010.1183/13993003.02249-2024