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About
In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.
Full description
This is a Phase III clinical study to investigate the efficacy and safety of FP-1201-lyo (recombinant human interferon [IFN] beta-1a) compared to placebo in patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). Primary objective is to demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation. Currently there are no approved drugs for treating moderate or severe ARDS patients.
FP-1201-lyo is a lyophilised powder form of recombinant human IFN beta-1a reconstituted in water for injection and is administered intravenously.
Recombinant human IFN beta-1a is an approved treatment for patients for other indication and its safety profile in such patients is well characterised.
Enrollment
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Inclusion criteria
All patients must be intubated and mechanically ventilated to diagnose ARDS and be eligible for the study
Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS:
Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
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 [moderate or severe ARDS] are present)
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
Hypoxaemia:
The radiological and hypoxaemia criteria (1.3 and 1.4) 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
Administration of the first dose of study drug must be planned to take place within 48 hours of moderate or severe ARDS diagnosis
Patient is intubated and mechanically ventilated
A signed informed consent form from the patient or the patient's personal legal representative or a professional legal representative must be available
Patient is aged ≥18 years
Exclusion criteria
Primary purpose
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Interventional model
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301 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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