Pirfenidone to Prevent Fibrosis in Ards.

NCT05075161 · tracked via the Priya Life Science Italy tracker

Sponsor

Università Vita-Salute San Raffaele

Phase

Phase 3

Started

2022-06-01

Last updated

2026-05-08

Condition(s) studied

Acute Respiratory Distress Syndrome (ARDS)

Investigational drug(s) / intervention(s)

Pirfenidone →Placebo

Pirfenidone: From days 1-7: 801mg/day; from days 8-14:1602mg/day, from day 15 to ICU discharge 2403 mg/day. All drugs will be delivered by a nasogastric tube divided in 3 daily doses.

Placebo: All drugs will be delivered by a nasogastric tube divided in 3 daily doses.

Study summary

Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized clinical trials, a specific and effective pharmacological approach for patients with ARDS is still lacking.

Fibroproliferation is a crucial part of the host defence response, and severe fibrotic lung disease affects ARDS patients even years after acute phase resolution.

Pirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated only in animal models.

This is a randomized controlled study to evaluate for the first time the efficacy of Pirfenidone in ARDS.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Concomitant presence of: * ARDS (moderate and severe) - Berlin definition 1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms 2. Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules 3. Respiratory failure not fully explained by cardiac failure or fluid overload 4. PaO2/FiO2\<200 mmHg with PEEP\<=5 cmH2O (invasive mechanical ventilation) * Inflammatory ARDS phenotype (28), defined by at least one of the following: 1. High plasma levels of inflammatory biomarkers 2. Vasopressor dependence 3. Lower serum bicarbonate or increased serum lactate * Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication. * Age \>=18 years Exclusion Criteria: * Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (\>7 days) up to the time of randomization * ARDS severe or moderate for more than 36 hours * Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF * ARF fully explained by left ventricular failure or fluid overload * Consent declined * Severe chronic respiratory disease requiring domiciliary ventilation * Clinical suspicion for significant restrictive lung disease * Pregnant women or women of childbearing potential who are sexually active * Known allergy to pirfenidone * Concomitant use of fluvoxamine * Known severe hepatic failure * Known severe renal failure or necessity of dialysis not related to acute disease * Little chance of survival (SAPS II score\>75)

Primary outcome measure(s)

The number of ventilator free days (VFD) at day 28. — 28 days
The primary outcome will be calculated following these rules: 1. the total number of days from day 1 to 28 post randomization on which a patient is alive and receives no assistance from mechanical ventilation, if any period of ventilator liberation lasts at least 48 consecutive hours. 2. study day 1 is the day of enrolment. 3. if patients are on mechanical ventilation they will be classified as being on mechanical ventilation for that entire study day. 4. to be considered liberated from mechanical ventilation, the patient will need to have at least 48 consecutive hours without mechanical ventilation. 5. non-invasive mechanical ventilation will not be considered assistance if it is provided by face or nasal mask. 6. patients dead before weaning will be allocated the value of 0 ventilator free days. Any patient who dies after weaning from mechanical ventilation but before day 28 will not have the days after their death until day 28 considered as a VFD.

Trial sites (17)

Facility	City	Region	Status
IRCCS San Raffaele Scientific Institute	Milan	MI	Recruiting
Ospedale Cesare Arrigo	Alessandria	Piedmont	Recruiting
Ospedale Santa Maria	Bari	Italy	Recruiting
ASST Spedali Civili di Brescia	Brescia	Italy	Recruiting
Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari	Cagliari	Italy	Recruiting
Ospedale di Merano	Merano	Italy	Recruiting
Ospedale Uboldo di Cernusco sul Naviglio	Milan	Italy	Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Italy	Recruiting
AOU Policlinico Paolo Giaccone	Palermo	Italy	Recruiting
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy	Recruiting
AOU Pisana	Pisa	Italy	Recruiting
A.O.R San Carlo	Potenza	Italy	Recruiting
Fondazione PTV - Policlinico Tor Vergata	Rome	Italy	Recruiting
Azienda Ospedaliero Universitaria Senese	Siena	Italy	Recruiting
AOU Città della Salute e della Scienza	Torino	Italy	Recruiting
Azienda Sanitaria Universitaria Integrata di Udine	Udine	Italy	Recruiting
Astana Medical University	Astana	Kazakhstan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05075161 on ClinicalTrials.gov ↗ ← All trials in Italy