Anakinra for Acute respiratory distress syndrome (ARDS)

Inclusion criteria

• {"criterion_text":"- 1.\tAge ≥ 18 years;"}
• {"criterion_text":"- 2.\tAny male and female;"}
• {"criterion_text":"- 3.\tPatients admitted to the ICU with a diagnosis within 48 hours of moderate-severe ARDS (PaO2/FiO2 < 200, PEEP ≥ 5 cmH2O) and needing intubation and mechanical ventilation;"}
• {"criterion_text":"- 4.\tBerlin clinical criteria for definition of ARDS: onset within 1 week of initial injury or of new or worsening respiratory symptoms, bilateral opacities not fully explained by effusion, lobar or pulmonary collapse or nodules, respiratory failure not fully explained by heart failure or fluid overload"}
• {"criterion_text":"- 5.\tARDS-like clinical-laboratory profile, defined by at least one of the following criteria: a. high plasma levels of inflammatory biomarkers (e.g., IL-6 > 80 pg/ml, PCR > 250 mg/l) b. dependence on vasopressors (of any type and at any dosage for at least one hour of treatment) c. decreased bicarbonatemia (< 18 mMol/L) or hyperlactacidemia (> 4 mMol/L)"}
• {"criterion_text":"- 6.\tInformed consent for participation in the study;"}
• {"criterion_text":"- 7.\tNegative swab for COVID-19."}

Exclusion criteria

• {"criterion_text":"- 1.\tAge < 18 years;"}
• {"criterion_text":"- 2.\tPregnant or lactating patients;"}
• {"criterion_text":"- 3.\tHypersensitivitỳ to the active ingredient or any of the excipients or to proteins derived from Escherichia coli;"}
• {"criterion_text":"- 4.\tConcomitant treatment with anti TNF-alpha;"}
• {"criterion_text":"- 5.\tNeutropenia (neutrophils <1.5 x 109/L);"}
• {"criterion_text":"- 6.\tPre-existing malignancies;"}
• {"criterion_text":"- 7.\tModerate-severe renal failure, creatinine CL <60 mL/minute."}

Primary endpoints

• {"endpoint_text":"- The main aim of this study is to evaluate ventilation-free days.","definition_or_measurement_approach":"No additional definition or measurement approach specified in the record beyond the statement of evaluating ventilation-free days."}

Secondary endpoints

• {"endpoint_text":"- 28-day mortality;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- ICU mortality;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- In-hospital mortality;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Improved PaO2/FiO2 ratio (measurement at day 0 and day 28);","definition_or_measurement_approach":"Measurement at day 0 and day 28"}
• {"endpoint_text":"- Driving pressure reduction (measurement at day 0 and day 28);","definition_or_measurement_approach":"Measurement at day 0 and day 28"}
• {"endpoint_text":"- Reduction peak pressure (measurement at day 0 and day 28);","definition_or_measurement_approach":"Measurement at day 0 and day 28"}
• {"endpoint_text":"- Reduction plateau pressure (measurement at day 0 and day 28);","definition_or_measurement_approach":"Measurement at day 0 and day 28"}
• {"endpoint_text":"- Days free from multi-organ damage calculated by Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) at day 28","definition_or_measurement_approach":"Calculated using Sequential Organ Failure Assessment methodology; SOFA score <2 at day 28"}

Other endpoints

• {"endpoint_text":"- Days free from multi-organ damage calculated by Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) at day 28 or last day of ICU admission if discharge occurs earlier, or at patient's death;","definition_or_measurement_approach":"Calculated by SOFA methodology; evaluated at day 28 or at last day of ICU admission if earlier, or at patient's death"}
• {"endpoint_text":"- Days free from renal function replacement treatment;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Peak creatininemia;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Peak AST/ALT/bilirubin;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Days free from vasoactive support;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Inpatient days after discharge from ICU;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- ICU Inpatient Days;","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Intrahospital inpatient days; - Cumulative dose of corticosteroids.","definition_or_measurement_approach":"Not specified"}

Italy

Earliest CTIS Part Ii Submission Date

25-10-2024

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

536

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Azienda Sanitaria Universitaria Friuli Centrale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy