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PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial - PIONEER
EU CTIS ID: 2024-514355-16-01
What this study is testing
The primary outcome of this clinical trial is to document an increase in the number of ventilator free days (VFD) at day 28 in the Pirfenidone group when compared to the placebo group.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ARDS (moderate and severe) based on the Berlin definition
- Inflammatory ARDS phenotype as defined by at least one of the following: 1) High plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, PCR > 250 mg/l); 2) Vasopressor dependence (any vasoconstrictor at any dosage for at least 1 hour); 3) Low serum bicarbonate (< 18 mmol/l) or increased serum lactate (>4 mmol/l)
- Informed consent expressed by the patient or by his/her legal representative or on Ethical Committee indication
You likely can't join if
- Age < 18 years
- Known allergy to Pirfenidone
- Concomitant use of Fluvoxamine
- Known severe hepatic failure either chronic (defined as a Child Plug class C) or acute, defined as: AST/ALT elevation >3 and ≤5 x ULN and bilirubin > 2 mg/dl or clinical signs and symptoms of hepatic damage; or AST/ALT elevation >5 x ULN
- Known severe renal failure (Cl-Creatinine less than 30 ml/min) either chronic or at the time of assessment; or necessity of dialysis either chronic or at the time of assessment
- Little chance of survival, as defined by a SAPS II score more than 75 points
See the full eligibility criteria
- ARDS (moderate and severe) based on the Berlin definition
- Inflammatory ARDS phenotype as defined by at least one of the following: 1) High plasma levels of inflammatory biomarkers (e.g. IL-6 > 80 pg/ml, PCR > 250 mg/l); 2) Vasopressor dependence (any vasoconstrictor at any dosage for at least 1 hour); 3) Low serum bicarbonate (< 18 mmol/l) or increased serum lactate (>4 mmol/l)
- Informed consent expressed by the patient or by his/her legal representative or on Ethical Committee indication
- Age < 18 years
- Known allergy to Pirfenidone
- Concomitant use of Fluvoxamine
- Known severe hepatic failure either chronic (defined as a Child Plug class C) or acute, defined as: AST/ALT elevation >3 and ≤5 x ULN and bilirubin > 2 mg/dl or clinical signs and symptoms of hepatic damage; or AST/ALT elevation >5 x ULN
- Known severe renal failure (Cl-Creatinine less than 30 ml/min) either chronic or at the time of assessment; or necessity of dialysis either chronic or at the time of assessment
- Little chance of survival, as defined by a SAPS II score more than 75 points
- 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 acute respiratory failure (ARF)
- ARF fully explained by left ventricular failure or fluid overload (determined by clinical assessment or echocardiography/cardiac output monitoring)
- Consent declined
- Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
- Clinical suspicion for significant restrictive lung disease (history of pulmonary fibrosis or suggestive pulmonary function tests)
- Women of childbearing potential who are sexually active and in whom a pregnancy test is either not available or positive at the time of enrolment. Women who are surgically sterile or sterile for any other reason are eligible, after providing medical evidence and maintaining it in the study file. Women who are post-menopausal as evidenced by the absence of menstruation for at least 1 year are eligible; the date of the last menstruation is to be recorded in the study file unless postmenopausal status is obvious due to age
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Kenya
- Russian Federation
- Taiwan
- Brazil
- Kazakhstan
- Qatar
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Kenya; Russian Federation; Taiwan; Brazil; Kazakhstan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.