Authorised Therapeutic confirmatory (Phase III) ACUTE RESPIRATORY DISTRESS SYNDROME

CLINICAL TRIAL WITH APROTININ IN THE ACUTE RESPIRATORY DISTRESS SYNDROME TREATMENT

EU CTIS ID: 2025-520826-39-00

What this study is testing

The primary objective of this study is to demonstrate the efficacy of aprotinin in improving clinical outcome and the need for mechanical ventilation in patients with moderate or severe ARDS.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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].
  • 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.
  • Administration of the first dose of study drug should be planned to occur within 48 hours of the diagnosis of moderate or severe ARDS.
  • The patient is intubated and receiving mechanical ventilation.
  • The patient is aged ≥18 years.

You likely can't join if

  • Woman known to be pregnant, breastfeeding, or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test.
  • The patient is receiving renal dialysis therapy due to chronic renal insufficiency.
  • 11. The patient is receiving extracorporeal membrane oxygenation, high frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung assist.
  • 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.
  • The patient has burns on ≥15% of his total body surface area.
  • The patient is concurrently participating in another pharmacotherapeutic protocol.
See the full eligibility criteria
Who can join
  • 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].
  • 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.
  • Administration of the first dose of study drug should be planned to occur within 48 hours of the diagnosis of moderate or severe ARDS.
  • The patient is intubated and receiving mechanical ventilation.
  • The patient is aged ≥18 years.
What rules you out
  • Woman known to be pregnant, breastfeeding, or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test.
  • The patient is receiving renal dialysis therapy due to chronic renal insufficiency.
  • 11. The patient is receiving extracorporeal membrane oxygenation, high frequency oscillatory ventilation (HFOV) or any form of extracorporeal lung assist.
  • 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.
  • The patient has burns on ≥15% of his total body surface area.
  • The patient is concurrently participating in another pharmacotherapeutic protocol.
  • The patient is not expected to survive for 24 hours.
  • 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.
  • 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).
  • The patient has acute left ventricular failure.
  • The patient has hepatic failure (Child-Pugh grade C).
  • The patient has received any previous IFN.
  • The patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.