Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Interferon beta-1a; Placebo
Intervention description: Investigational drug; Placebo for investigational drug
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ARDS, human; Acute Respiratory Distress Syndrome; Respiratory Insufficiency

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        All patients must be intubated and mechanically ventilated to diagnose ARDS and be eligible
        for the study

          1. 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:

                    -  Moderate ARDS: PaO2/FiO2 >100 mmHg (>13.3 kPa) to ≤200 mmHg (≤26.6 kPa) with
                       positive end expiratory pressure (PEEP) ≥5 cmH2O

                    -  Severe ARDS: PaO2/FiO2 ≤100 mmHg (≤13.3 kPa) with positive end expiratory
                       pressure [PEEP] ≥5 centimeter of water [cmH2O]

          2. 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

          3. Administration of the first dose of study drug must be planned to take place within 48
             hours of moderate or severe ARDS diagnosis

          4. Patient is intubated and mechanically ventilated

          5. A signed informed consent form from the patient or the patient's personal legal
             representative or a professional legal representative must be available

          6. Patient is aged ≥18 years

        Exclusion Criteria:

          1. Woman known to be pregnant, lactating or with a positive (urine or serum test) or
             indeterminate (serum test) pregnancy test

          2. Patient is simultaneously taking part in another pharmacotherapy protocol

          3. 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 neurone 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 IV

          7. Patient has acute left ventricular failure

          8. Patient has liver failure (Child-Pugh grade C)

          9. Patient has received any prior interferon

         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 extra-corporeal 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