se of Pirfenidone in the prevention of fibrosis in patients with acute respiratory distress syndrome (ARDS): clinical trial to prevent the onset of pulmonary fibrosis in patients with ARDS

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS); MedDRA version: 21.1Level: LLTClassification code 10003083Term: ARDSSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-005306-25-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Concomitant presence of:
1. ARDS (moderate and severe)
2. Inflammatory ARDS phenotype (28), defined by at least one of the following:
- High plasma levels of inflammatory biomarkers
- Vasopressor dependence
- Lower serum bicarbonate or increased serum lactate
-Informed consent expressed by the patient or by legal representative or on the Ethical Committee indication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Intubated and mechanically ventilated via an endotracheal or tracheostomy tube (>7 days) up to the time of randomization
2. ARDS severe or moderate for more than 36 hours
3. Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of ARF
4. ARF fully explained by left ventricular failure or fluid overload
5. Consent declined
6. Severe chronic respiratory disease requiring domiciliary ventilation
7. Clinical suspicion for significant restrictive lung disease
8. Pregnant women ore women of childbearing potential who are sexually active
9. Known allergy to pirfenidone
10.Concomitant use of fluvoxamine
11. Known severe hepatic failure
12. Known severe renal failure or necessity of dialysis not related to acute disease
13. Little chance of survival (SAPS II score>75)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified