Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT05075161
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05075161
Study Brief:
Protocol Section:
NCT05075161