Acute Respiratory Distress Syndrome (ARDS)
Conditions
Interventions
investigational material(s)
Generic name etc : Recombinant Human Interferon Beta-1a
INN of investigational material : Interferon beta-1a
Therapeutic category code : 229 Other agents affecting respirat
Sponsors
Maruishi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS a) Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms b) Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS are present) c) Radiological abnormalities on chest X-ray or on computerised tomography scan, i.e., bilateral opacities that are not fully explained by effusions, nodules, masses or lobar/lung collapse d) Hypoxaemia Moderate ARDS 100mmHg=5cmH2O Severe ARDS PaO2/FiO2=5cmH2O (2) The radiological and hypoxaemia criteria in ARDS criteria (c and d) must be met within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met (3) Administration of the first dose of study drug must be planned to take place within 48 hours of first fulfilling the above inclusion criteria (4) Patient is intubated and mechanically ventilated (5) A signed informed consent form from the patient or the patients personal legal representative or a professional legal representative must be available
Exclusion criteria
Exclusion criteria: (1) Woman known to be pregnant, lactating or with a positive or indeterminate pregnancy test (2) Patient is simultaneously taking part in another pharmacotherapy protocol (3) The patient is not expected to survive for 24 hours (4) Patient has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation, e.g., motor neuron disease, Duchenne muscular dystrophy or rapidly progressive interstitial pulmonary fibrosis (5) Patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure used solely for sleep-disordered breathing (6) Patient has congestive heart failure, defined as New York Heart Association class 4 (7) Patient has acute left ventricular failure (8) Patient has liver failure (Child-Pugh grade C) (9) Patient has received any prior interferon (IFN) (10) Patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients (11) Patient is receiving renal dialysis therapy for chronic renal failure (12) Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extracorporeal lung support (13) Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 hours prior to the diagnosis of ARDS. Non-invasive ventilation has to be continuously applied for at least 12 hours per day in these 48 hours (14) Patient has burns to >_15% of their total body surface area (15) Patient is receiving Sho-saiko-to or is scheduled to receive Sho-saiko-to during the study drug administration period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety To demonstrate the efficacy of MR11A8 on all-cause mortality at Day28 compared with placebo Day28 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety Composite endpoint including any-cause death at D28 and days free of mechanical ventilation within 28 days among survivors All-cause mortality at Day90 Mortality in ICU up to Day28 Mortality in hospital up to Day28 Up to Day28, Day90 | — |
Countries
Japan
Outcome results
None listed