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Journal Article Randomized Controlled Trial Clinical Trial, Phase II Multicenter Study Epublish 9 citations

PubMed: 40154560 DOI: 10.1183/13993003.02249-2024

Pirfenidone in post-COVID-19 pulmonary fibrosis (FIBRO-COVID): a phase 2 randomised clinical trial.

Eur Respir J 65(4)

Authors: Guadalupe Bermudo-Peloche, Belén Del Rio, Vanesa Vicens-Zygmunt, Jaume Bordas-Martinez, Marta Hernández, Claudia Valenzuela, Rosalía Laporta, Juan Rigual Bobillo, Karina Portillo, Paloma Millán-Billi, Eva Balcells, Diana Badenes-Bonet, Santi Bolivar, José-Antonio Rodríguez-Portal, Cecilia López Ramirez, Laura Tomás, Koral Fernández de Roitegi, Jacobo Sellarés, Diego Castillo, Jessica González, Silvia Barril, Yasmina Gutiérrez-Rodríguez, Paloma Caballero, Javier Alarcon, Judith Peñafiel, Jose Sanz-Santos, Rosana Blavia, Cristina Caupena, Pilar Segovia, Salud Santos-Pérez, Anna Ferrer-Artola, Maria B Badia, Pilar Hereu, Mireya Fuentes, Ana Montes-Worboys, Tomás Franquet, Patricio Luburich, María Molina-Molina

Affiliations

  • Interstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
  • National Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
  • Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
  • Interstitial Lung Disease Unit, Radiology Department, Bellvitge University Hospital, University of Barcelona - L'Hospitalet de Llobregat, Barcelona, Spain.
  • Interstitial Lung Disease Unit, Respiratory Department, Hospital La Princesa, Madrid, Spain.
  • Respiratory Department, Hospital Puerta Hierro, Majadahonda, Spain.
  • Respiratory Department, Universidad de Alcalá-IRYCIS, Hospital Ramón y Cajal, Madrid, Spain.
  • Respiratory Department, Hospital Germans Trias i Pujol, Badalona, Spain.
  • Respiratory Department, Hospital del Mar, Department of Medicine and Life Sciences, Universitat Pompeu Fabra (UPF), Barcelona, Spain.
  • Interstitial Lung Disease Unit, Respiratory Department, Hospital Virgen del Rocío, Sevilla, Spain.
  • Respiratory Department, Hospital Txagorritxu, Vitoria, Spain.
  • Interstitial Lung Disease Unit, Respiratory Department, Hospital Clínic, Barcelona, Spain.
  • Respiratory Department, Hospital Sant Pau i Santa Creu, Barcelona, Spain.
  • Translational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain.
  • Interstitial Lung Disease Unit, Radiology Department, Hospital La Princesa, Madrid, Spain.
  • Interstitial Lung Disease Unit, Department of Radiology, Hospital Ramón y Cajal, Madrid, Spain.
  • Department of Biostatistics, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
  • Respiratory Department, Hospital Mutua Terrassa, Terrassa, Spain.
  • Respiratory Department, Hospital Moises Broggi, Sant Joan d'Espí, Spain.
  • Respiratory Department, Hospital General del Parc Sanitari Sant Joan de Dèu, Sant Boi de Llobregat, Spain.
  • Respiratory Department, Hospital de Figueres, Figueres, Spain.
  • Department of Pharmacy, University Hospital of Bellvitge, Grupo de Investigación Farmacoterapia, Farmacogenética y Tecnología Farmacéutica, Programa de Sistema Digestivo, Diagnóstico, Farmacogenética, Enfermería y Prevención, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
  • Clinical Pharmacology Department, Bellvitge University Hospital, IDIBELL, Clinical Research and Clinical Trial Unit-IDIBELL, University of Barcelona, Barcelona, Spain.
  • Department of Radiology, Hospital Sant Pau i Santa Creu, Barcelona, Spain.
  • Interstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.

Abstract

BACKGROUND

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.

MeSH

Quality Of Life, Lung, Safety, Fibrosis, Respiratory Tract Diseases, Respiration, Pharmaceutical Preparations, Covid-19, Pulmonary Fibrosis, Vital Capacity

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