Aprotinin for Acute respiratory distress syndrome

Inclusion criteria

• {"criterion_text":"- The patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS (Ref: ARDS Definition Task Force 2012): 1.1 Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms. 1.2 Respiratory failure associated with known ARDS risk factors and not fully explained by either heart failure or fluid overload (objective assessment of heart failure or fluid overload is required if there are no risk factors for ARDS [moderate or severe ARDS].\n- The radiological and hypoxemia criteria (1.3 and 1.4) must occur within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met.\n- Administration of the first dose of study drug should be planned to occur within 48 hours of the diagnosis of moderate or severe ARDS.\n- The patient is intubated and receiving mechanical ventilation.\n- The patient is aged ≥18 years."}

Exclusion criteria

• {"criterion_text":"- Woman known to be pregnant, breastfeeding, or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test.\n- The patient is receiving renal dialysis therapy due to chronic renal insufficiency.\n- 11. The patient is receiving extracorporeal membrane oxygenation, high frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung assist.\n- The patient has received any form of mechanical ventilation (invasive or noninvasive, excluding CPAP alone) for more than 48 hours prior to the diagnosis of ARDS. Non-invasive ventilation has to be applied continuously for at least 12 hours per day during those 48 hours.\n- The patient has burns on ≥15% of his total body surface area.\n- The patient is concurrently participating in another pharmacotherapeutic protocol.\n- The patient is not expected to survive for 24 hours.\n- The patient has an underlying clinical condition in which, in the opinion of the investigator, withdrawal of ventilation would be extremely unlikely, e.g., motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis.\n- The patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or by tracheostomy), except continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) used only for sleep disordered breathing.The patient has congestive heart failure, defined as New York Heart Association class IV (Reference: Committee for Medicinal Products for Human Use 1994).\n- The patient has acute left ventricular failure.\n- The patient has hepatic failure (Child-Pugh grade C).\n- The patient has received any previous IFN.\n- The patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients."}

Primary endpoints

• {"endpoint_text":"- primary efficacy: For the primary endpoint, ventilator-free days (DLVI) will be calculated. A patient will be considered ventilator-free after two consecutive calendar days of unassisted ventilation. These variables will also be assessed at D90 in an exploratory analysis.","definition_or_measurement_approach":"Ventilator-free days (DLVI) calculated; patient considered ventilator-free after two consecutive calendar days of unassisted ventilation. Variables also assessed at Day 90 in an exploratory analysis."}

Secondary endpoints

• {"endpoint_text":"- secondary efficacy: All-cause mortality will be assessed at D28 (primary) and also at D90 and D180. All deaths will be recorded as EAS up to D180. The location of the patient at the time of death (ICU or hospital) will also be recorded. SOFA, renal support, vasoactive support, respiratory functioning, persistent weakness and neuropsychological disorders (D180).","definition_or_measurement_approach":"All-cause mortality assessed at Day 28 (primary), and also at Day 90 and Day 180; all deaths recorded as EAS up to Day 180; location at time of death recorded; SOFA, renal and vasoactive support, respiratory function, persistent weakness and neuropsychological disorders assessed at D180."}
• {"endpoint_text":"- safety: Adverse Event Evaluation, Causality, Adverse Event in Clinical Laboratory, Adverse Event Recording, Serious Adverse Event Reporting, Adverse Event Follow-Up, Adverse Event Monitoring","definition_or_measurement_approach":"Standard adverse event collection, causality assessment, laboratory AE reporting, SAE reporting and follow-up as specified in safety reporting procedures."}
• {"endpoint_text":"- laboratory: Blood samples will be taken for biochemistry and hematology at screening, prior to dosing on D1 (baseline) and daily until D28 while the patient is in the ICU.","definition_or_measurement_approach":"Biochemistry and hematology samples at screening, pre-dose on Day 1 baseline, and daily until Day 28 while in ICU."}
• {"endpoint_text":"- vital signs: - Blood pressure (systolic, diastolic and mean; mmHg): to be recorded through an arterial line. - Heart rate (HR; bpm): measured according to clinical practice in each ICU. - Total respiratory rate (breaths per minute). - Temperature (°C) - ECG","definition_or_measurement_approach":"Vital signs recorded per ICU clinical practice: arterial-line blood pressure (systolic/diastolic/mean), heart rate, respiratory rate, temperature, ECG."}

Spain

Earliest CTIS Part Ii Submission Date

02-06-2025

Latest Decision Or Authorization Date

04-02-2026

Processing Time Days

247

Number Of Sites

13

Number Of Participants

156

Primary sponsor

Full Name

Fundacion Del Hospital Nacional De Paraplejicos Para La Investigacion Y La Integracion

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain