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NCT07317050

PHASE3

Clinical Trial With Aprotinin in the Acute Respiratory Distress Syndrome Treatment

Sponsor: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

View on ClinicalTrials.gov

Summary

This is a multicentre, double-blind, placebo-controlled Phase III randomized clinical trial designed to evaluate the efficacy and safety of inhaled aprotinin in adult patients with moderate or severe acute respiratory distress syndrome (ARDS). A total of 156 critically ill patients admitted to intensive care units will be randomized to receive either inhaled aprotinin or placebo in addition to standard supportive care. The primary objective is to determine whether aprotinin improves clinical outcomes based on a composite endpoint of mortality and ventilator-free days at 28 days.

Official title: Aprotinin Treatment of Acute Respiratory Distress Syndrome: a Multicenter, Double-blind, Placebo-controlled, Phase III Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

156

Start Date

2026-03-01

Completion Date

2030-03-01

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

DRUG

Aprotinin (inhaled)

Inhaled aprotinin, diluted in 0.9% sodium chloride, is administrated via nebulization through an endotracheal or tracheostomy tube. The dose is 500 UI every 6 hours (totaling 2,000 UI/day) for six consecutive days. Each administration consists of a nebulized inhalation lasting no less than six minutes, with four inhalations delivered per day. Nebulization is performed using Aerogen® Solo vibrating mesh nebulizers to maintain a closed ventilatory circuit. The device produces aerosol particles with a median diameter of 2-10 µm; 30-50% of these aggregates reach diameters of 50-100 µm. Administration follows pharmacy blinding procedures. All patients receive standard supportive care according to local practice.

DRUG

Placebo (Sodium Chloride)

Placebo (sodium chloride) is administered by inhalation via endotracheal or tracheostomy tube using the Aerogen® Solo vibrating mesh nebulizer, four times daily for six consecutive days. It is delivered following the same dosing schedule, device specifications, and administration procedures as the active treatment. Administration follows pharmacy blinding procedures to maintain double-blind conditions. All patients receive standard supportive care according to local practice.

Inclusion Criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition (ARDS Definition Task Force 2012): * Acute onset of respiratory failure within 1 week of a known clinical insult or new/worsening respiratory symptoms. * Respiratory failure not fully explained by cardiac failure or fluid overload; objective evaluation of cardiac failure or fluid overload is required if ARDS risk factors are absent. * Radiographic abnormalities on chest X-ray or CT scan: bilateral opacities not fully explained by effusions, nodules, masses, or lobar/segmental collapse. * Hypoxemia: * Moderate ARDS: PaO₂/FiO₂ \>100 mmHg and ≤200 mmHg with Positive End-Expiratory Pressure (PEEP) ≥5 cmH₂O. * Severe ARDS: PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cmH₂O. 2. Radiographic and hypoxemia criteria must occur within the same 24-hour period. ARDS onset is defined as the time when the last of these two criteria is met. 3. First dose of study drug planned within 48 hours of moderate or severe ARDS diagnosis. 4. Intubated and receiving mechanical ventilation. 5. Age ≥18 years. 6. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at study start. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use an effective contraceptive method from consent until 30 days after study drug administration. Exclusion Criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Pregnant or lactating women, or positive/indeterminate pregnancy test (serum or urine). 2. Simultaneous participation in another pharmacotherapy protocol. 3. Life expectancy \<24 hours. 4. Clinical condition in which, in the investigator's opinion, ventilator withdrawal is extremely unlikely (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial lung disease). 5. Severe chronic obstructive pulmonary disease requiring long-term home oxygen or mechanical ventilation (noninvasive or tracheostomy), except Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) used solely for sleep-related respiratory disorders. 6. Congestive heart failure defined as New York Heart Association (NYHA) class IV. 7. Acute left ventricular failure. 8. Severe hepatic impairment (Child-Pugh class C). 9. Prior interferon therapy. 10. Known hypersensitivity to natural or recombinant IFN beta or any excipients. 11. Receiving renal dialysisfor chronic renal failure. 12. Receiving extracorporeal membrane oxygenation (ECMO), high-frequency oscillatory ventilation, or any form of extracorporeal pulmonary support. 13. Mechanical ventilation, (invasive or noninvasive, excluding CPAP alone), for more than 48 hours before ARDS diagnosis. Noninvasive ventilation must be applied continuously for at least 12 hours/day during those 48 hours. 14. Burns covering ≥15% total body surface. 15. Women with positive pregnancy test at screening (serum) or study start (urine); lactating subjects; subjects planning pregnancy within 1 month after the study (including male partners).

Locations (1)

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain