AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Pirfenidone to Prevent Fibrosis in Ards.

RecruitingPhase 3Ages 18 Years - anyAllUniversitร  Vita-Salute San Raffaele
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
๐Ÿ’Š

What it tests

  • Pirfenidone
  • Placebo
๐Ÿ“

Where

17 sites
IRCCS San Raffaele Scientific Institute
Milan, Italy
Ospedale Cesare Arrigo
Alessandria, Italy
Ospedale Santa Maria
Bari, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari
Cagliari, Italy
Ospedale di Merano
Merano, Italy
Ospedale Uboldo di Cernusco sul Naviglio
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy