Bermudo-Peloche, GuadalupeDel Rio, BelénVicens-Zygmunt, VanesaBordas Martínez, JaumeHernández, MartaValenzuela, ClaudiaLaporta, RosalíaRigual Bobillo, JuanPortillo, KarinaMillán-Billi, PalomaBalcells, EvaBadenes Bonet, DianaBolivar, SantiRodríguez-Portal, José AntonioLópez Ramirez, CeciliaTomás, LauraFernández de Roitegi, KoralSellarés Torres, JacoboCastillo Villegas, DiegoGonzalez-Cabrera, JoaquínBarril, SilviaGutiérrez Rodríguez, YasminaCaballero, PalomaAlarcon, JavierPeñafiel, JudithSanz-Santos, JoseBlavia, RosanaCaupena, CristinaSegovia, PilarSantos-Pérez, SaludFerrer-Artola, AnnaBadia, Maria B.Hereu Boher, PilarFuentes Prado, MireyaMontes Worboys, AnaFranquet, TomásLuburich Hernaiz, PatricioMolina Molina, María2025-08-282025-08-282025-04-240903-1936https://hdl.handle.net/2445/222805Background: 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. Methods: 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), exercise capacity and drug safety profile. Results: From 119 eligible patients, 113 were randomised and 103 were analysed (pirfenidone n=69 and placebo n=34). Most patients were male (73.5%) and were receiving low-dose prednisone; mean age was 63.7 years and mean body mass index was 29 kg·m-2. The percentage of patients that improved was similar in the pirfenidone and placebo groups (79.7% versus 82.3%, respectively). The mean predicted FVC increased by 12.74±20.6% with pirfenidone and 4.35±22.3% with placebo (p=0.071), and the HRCT (%) fibrotic score decreased by 5.44±3.69% with pirfenidone and 2.57±2.59% with placebo (p=0.52). Clinically meaningful improvement in HRQoL was not statistically different (55.2% in the pirfenidone group and 39.4% in the placebo group). Exercise capacity, adverse events and hospitalisations were similar between groups. No deaths were reported. Conclusions: The overall improvements in lung function and HRCT fibrotic score after 6 months with pirfenidone were not significantly different than with placebo.11 p.application/pdfengcc by-nc (c) Bermudo-Peloche, Guadalupe et al., 2025https://creativecommons.org/licenses/by-nc/4.0/COVID-19Agents antiinflamatorisFibrosi pulmonarCOVID-19Antiinflammatory agentsPulmonary fibrosisinfo:eu-repo/semantics/article7589412025-08-28info:eu-repo/semantics/openAccess40154560