Pirfenidone to Prevent Fibrosis in Ards.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele
About this trial
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 criteria
Qualifiers
ARDS (moderate and severe) - Berlin definition
Within 1 week of a known clinical insult or new or worsening respiratory symptoms
Bilateral opacities on CXR which are not fully explained by effusions, lobar/lung collapse or nodules
Respiratory failure not fully explained by cardiac failure or fluid overload
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pirfenidone
- Placebo
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov