Evidence map›Paper›PMID 40154560›Full record

Trial reportThe European respiratory journal2025

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

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 and 28 more

Erratum issuedAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The European respiratory journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Pirfenidone in post-COVID-19 pulmonary fibrosis.The European respiratory journal · 2025
    Article
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

38 authors.

Guadalupe Bermudo-PelocheInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Belén Del RioInterstitial Lung Disease Unit, Radiology Department, Bellvitge University Hospital, University of Barcelona - L'Hospitalet de Llobregat, Barcelona, Spain.
Vanesa Vicens-ZygmuntInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID https://orcid.org/0000-0002-0940-3215
Jaume Bordas-MartinezInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID https://orcid.org/0000-0003-4027-8907
Marta HernándezInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Claudia ValenzuelaNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.ORCID https://orcid.org/0000-0002-0856-6290
Rosalía LaportaNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Juan Rigual BobilloRespiratory Department, Universidad de Alcalá-IRYCIS, Hospital Ramón y Cajal, Madrid, Spain.ORCID https://orcid.org/0000-0002-2753-9538
Karina PortilloNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Paloma Millán-BilliRespiratory Department, Hospital Germans Trias i Pujol, Badalona, Spain.ORCID https://orcid.org/0000-0003-4664-0516
Eva BalcellsNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Diana Badenes-BonetRespiratory Department, Hospital del Mar, Department of Medicine and Life Sciences, Universitat Pompeu Fabra (UPF), Barcelona, Spain.
Santi BolivarInterstitial Lung Disease Unit, Radiology Department, Bellvitge University Hospital, University of Barcelona - L'Hospitalet de Llobregat, Barcelona, Spain.
José-Antonio Rodríguez-PortalNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Cecilia López RamirezInterstitial Lung Disease Unit, Respiratory Department, Hospital Virgen del Rocío, Sevilla, Spain.
Laura TomásRespiratory Department, Hospital Txagorritxu, Vitoria, Spain.
Koral Fernández de RoitegiRespiratory Department, Hospital Txagorritxu, Vitoria, Spain.
Jacobo SellarésNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Diego CastilloNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.ORCID https://orcid.org/0000-0002-4862-3595
Jessica GonzálezNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
Silvia BarrilTranslational Research in Respiratory Medicine, University Hospital Arnau de Vilanova and Santa Maria, IRBLleida, Lleida, Spain.
Yasmina Gutiérrez-RodríguezInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Paloma CaballeroInterstitial Lung Disease Unit, Radiology Department, Hospital La Princesa, Madrid, Spain.
Javier AlarconInterstitial Lung Disease Unit, Department of Radiology, Hospital Ramón y Cajal, Madrid, Spain.
Judith PeñafielDepartment of Biostatistics, IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Jose Sanz-SantosRespiratory Department, Hospital Mutua Terrassa, Terrassa, Spain.
Rosana BlaviaRespiratory Department, Hospital Moises Broggi, Sant Joan d'Espí, Spain.
Cristina CaupenaRespiratory Department, Hospital General del Parc Sanitari Sant Joan de Dèu, Sant Boi de Llobregat, Spain.
Pilar SegoviaRespiratory Department, Hospital de Figueres, Figueres, Spain.
Salud Santos-PérezInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Anna Ferrer-ArtolaBellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Maria B BadiaBellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Pilar HereuBellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Mireya FuentesInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Ana Montes-WorboysInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.
Tomás FranquetDepartment of Radiology, Hospital Sant Pau i Santa Creu, Barcelona, Spain.
Patricio LuburichNational Network of Research in Respiratory Diseases (CIBERES), Barcelona, Spain.
María Molina-MolinaInterstitial Lung Disease Unit, Respiratory Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain mariamolinamolina@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients 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.

methodsThis 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.

resultsFrom 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

conclusionsThe overall improvements in lung function and HRCT fibrotic score after 6 months with pirfenidone were not significantly different than with placebo.

Indexed as

COVID-19COVID-19 Drug TreatmentPulmonary FibrosisPyridonesAgedAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodExercise ToleranceFemaleHumansIdiopathic Pulmonary FibrosisLungMaleMiddle AgedQuality of LifeTomography, X-Ray ComputedAnti-Inflammatory Agents, Non-SteroidalpirfenidonePyridones

Identifiers

PMID40154560
PMCPMC12018760

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.