Adult patients diagnosed with moderate or severe Acute Respiratory Distress Syndrome (ARDS) MedDRA version: 20.0 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
Conditions
Sponsors
Faron Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion 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: 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 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) 1.3 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 1.4 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 PEEP =5 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
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 hrs per day in these 48 hours 14. Patient has burns to =15% of their total body surface area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation in patients with moderate or severe acute respiratory distress syndrome (ARDS); Secondary Objective: Safety • the safety of FP-1201-lyo compared with placebo Efficacy • 28-day all-cause mortality of FP-1201-lyo compared with placebo • all-cause mortality at other selected time points • the efficacy of FP-1201-lyo compared with placebo by assessing: - days free of organ failure, of renal support, of vasoactive support, of mechanical ventilation and number of intensive care unit (ICU) -free days - number of days in hospital • the immunogenicity • the pharmacodynamics (PD) of FP-1201-lyo with myxovirus resistance protein A (MxA) • patient outcomes for respiratory and neurological functioning and quality of life (QoL) Pharmacoeconomics • selected parameters Exploratory • gas exchange during mechanical ventilation • the PD of FP-1201-lyo using the (CD)73 biomarker • selected potential inflammatory markers (PIM) • Blood sample for future pharmacogenetic analysis • all-cause mortality, QoL, and respiratory and neurological functioning follow-up (Day 360) ; Primary end point(s): Primary Efficacy Endpoint: • Composite endpoint including any cause of death at D28 and days free of mechanical ventilation (VFDsurv) within 28 days among survivors ;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Secondary efficacy endpoints relating to the efficacy of FP-1201-lyo treatment: - All-cause mortality at D28, D90 and D180 - Mortality in ICU up to D28 - Mortality in hospital up to D28 • Other secondary efficacy endpoints at D28: - Days free of organ failure (Sequential Organ Failure Assessment methodology) (D28 or last day in ICU if Patient has left the ICU earlier than D28, or at withdrawal) - Days free of renal support - Days free of vasoactive support - Days free of mechanical ventilation - Number of ICU free days - Number of days in hospital • Presence of neutralising antibodies to IFN beta-1a at baseline and D28 (or last day in ICU if patient has left the ICU earlier than D28 or at withdrawal) • Evaluation of PD using MxA biomarker from baseline to D14 • Long-term secondary endpoints, relating to QoL, respiratory and neurological functioning at D180: - EQ-5D-3L - 6MWT - FEV1 Evaluation of safety: • Adverse events up to D28, AEs occurring after D28 if the investigator considers there is a causal relationship with the the study drug and all deaths up to D360. • Physical examination, vital signs and laboratory results (biochemistry, haematology and urinalysis) up to D28 (or last day in ICU if Patient has left the ICU earlier than D28, or at withdrawal) Evaluation of pharmacoeconomics at D28: - Days free of organ failure (D28 or last day ICU if Patient has left the ICU earlier than D28, or at withdrawal) - Days free of renal support - Days free of vasoactive support - Days free of mechanical ventilation - Number | — |
Countries
Belgium, Czech Republic, Finland, Germany, Spain
Contacts
Public ContactCMO, VP Drug Development
Faron Pharmaceuticals Ltd
Outcome results
None listed