Pirfenidone to prevent fibrosis in acute respiratory distress syndrome: The PIONEER study protocol
Journal
Contemporary Clinical Trials
Series/Report No.
Contemporary Clinical Trials
Journal Volume
153
Start Page
107883
ISSN
1551-7144
Date Issued
2025-06
Author(s)
Monti, Giacomo
Marzaroli, Matteo
Tucciariello, Maria Teresa
Ferrara, Brian
Meroi, Francesco
Nakhnoukh, Cristina
Zambon, Massimo
Borghi, Giovanni
Guarracino, Fabio
Manazza, Marco
Ajello, Valentina
Belletti, Alessandro
Biuzzi, Cesare
Plumari, Valentina
Filippini, Matteo
Cuffaro, Raffaele
Racanelli, Gabriele
Pontillo, Domenico
Rauch, Simon
Oliva, Federico Mattia
Tescione, Marco
Baiardo Redaelli, Martina
Melegari, Gabriele
Maj, Giulia
Navalesi, Paolo
Gerardi, Michele
Caccioppola, Alessio
Bruni, Andrea
Ballotta, Andrea
Ferri, Camilla
Orso, Daniele
Di Benedetto, Vincenzo
Baldassarri, Rubia
Franceschini, Giulia
Alamami, Ans
Pasin, Laura
Putzu, Alessandro
Romero Garcia, Carolina Soledad
et al.
Abstract
Background: Pulmonary fibrosis is a major complication of the Acute Respiratory Distress Syndrome (ARDS). Pirfenidone is an approved treatment for idiopathic pulmonary fibrosis. It may attenuate ARDS-related fibrosis and decrease the need for prolonged ventilation. Accordingly, we aimed to evaluate the effect of pirfenidone on ventilator-free days in patients with ARDS.
Methods: In a multi-center, randomized, double-blind, placebo-controlled trial, we plan to randomly assign 130 adults invasively ventilated for ARDS to receive pirfenidone or placebo for up to 28 days. The primary outcome is days alive and ventilator free at 28 days. Secondary outcomes include ICU-free days, hospital free days all at 28 day, ICU mortality and hospital mortality. We will also assess fibroproliferative changes on high-resolution CT scans at ICU discharge and quality of life. Data analysis will be on an intention-to-treat basis.
Discussion: The trial is ongoing and currently recruiting. It will be the first randomized controlled study to investigate whether, compared to placebo, pirfenidone increases the number of days alive and ventilator-free in patients with ARDS. Its double-blind multicenter design will provide internal validity, minimal bias, and a degree of external validity. If our hypothesis is confirmed, this treatment would justify larger trials of this intervention.
Trial registration: This trial was registered on ClinicalTrials.gov with the trial identification NCT05075161.
Subjects
ARDS
Critical care
Fibrosis
Intensive care
Mechanical ventilation
Pirfenidone
SDGs
Publisher
Elsevier BV
Type
journal article