Aprotinin inhaled for moderate to severe ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, placebo-controlled Phase III trial randomizes 156 adult ICU patients with moderate to severe ARDS to receive inhaled aprotinin or placebo in addition to standard supportive care. Aprotinin targets inflammatory pathways in the lungs, with the aim of improving outcomes such as days free from ventilator support within 28 days. The study uses a 1:1 allocation and follows patients for safety and efficacy endpoints in a real-world critical care setting. Enrollment requires Berlin-defined ARDS criteria with onset within one week and objective hypoxemia and radiographic findings. The primary goal is to determine if inhaled aprotinin increases ventilator-free days at 28 days compared with placebo.

Why it matters

Who can join: the full rules

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).

Where it's running

• Hospital General Universitario de Ciudad Real
  Ciudad Real, Ciudad Real, Spain Recruiting

Study contacts

• Study coordinator: Francisco Javier Redondo Calvo, MD, PhD
• Email: fjredondo@sescam.jccm.es
• Phone: +34 926 27 80 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.