patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
Conditions
Interventions
Trade Name: CUROSURF®
Product Name: CUROSURF®
Product Code: CHF 1534
Pharmaceutical Form: Suspension for injection
Sponsors
CHIESI FARMACEUTICI S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18 and = 80 years of age 2. Informed consent for participation in the study (refer to section 15 for detailed informed consent procedure) 3. Positive 2019-nCoV rt-PCR before randomisation 4. PaO2/FiO2 ratio =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Any contraindications to surfactant administration e.g., pulmonary haemorrhage and pneumothorax) 2. Weight < 40kg 3. Stage 4 severe chronic kidney disease (i.e., eGFR < 30) 4. Pregnancy 5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration 6. Extracorporeal membrane oxygenation* * [Exclusion criterion NOT applicable for patients eligible for the ECMO-cohort]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the investigational drug Curosurf®, administered by endotracheal (ET) instillation in terms of ventilatory free days in adult patients with Acute Respiratory Distress Syndrome (ARDS) due to 2019-nCoV infection. The same evaluation is planned in a separate cohort of patients under extracorporeal membrane oxygenation (vvECMO) in terms of ECMO free days during the 21 days after randomization.;Secondary Objective: To evaluate the efficacy and safety of Curosurf® administered by ET Instillation compared to control cohort (patient not treated with Curosurf®), in terms of oxygenation (PaO2 / FiO2), FiO2, free days from invasive and non-invasive mechanical ventilation, length of Intensive Care Units (ICU)stay, mortality at 28 days, SOFA score (overall organ -failure measurement), duration and free days from ECMO (applicable only for ECMO-cohort),incidence of AEs, vital signs and laboratory parameters,incidence of adverse events, vital signs and laboratory parameters.;Primary end point(s): The primary outcome variable will be the number of ventilator-free days defined as the number of days the patient is not receiving mechanical ventilation during the 21 days after randomisation. Mechanical ventilation will be defined as invasive and non-invasive. Patient will be defined free of mechanical ventilation after 12 hours from the suspension of any type of both invasive and non-invasive ventilation.;Timepoint(s) of evaluation of this end point: Starting from the 21 days after ranfomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of free days from invasive ventilation - Number of free days from non-invasive ventilation (NIV) - Change from baseline in PaO2/FiO2 ratio at 6 and 12 hours following each dose administration in the treated group relative timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation) - Change from baseline in PaO2/FiO2 ratio at additional timepoints (i.e. every 24 hours since treatment/randomisation till the patient is discharged from the ICU) - Percentage of patients with PaO2/ FiO2 improvement >20% at 6 and 12 hours following each dose administration in the treated group and relative timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation) - Percentage of patients with PaO2/ FiO2 improvement >20% at additional timepoints (i.e. every 24 hours after treatment/randomisation till the patient is discharged from the ICU) - Change from baseline in FiO2 at 6 and 12 hours following each dose administration in the treated group and relative timepoints in the control group (6, 12, 30, 36, 54 and 60 hours after randomisation) - Change from baseline in FiO2 at additional timepoints (i.e. every 24 hours after treatment/randomisation till the patient is discharged from the ICU) - Length of ICU stay (days) - Mortality at Day 28 - Delta SOFA Score measured on Day 3 at Discharge and Day 28 - Change from baseline in ventilatory parameters [tidal volume (TV), respiratory rate (RR), dynamic compliance (Cdyn), static compliance (Cstat), positive end-expiratory pressure (PEEP), peak inspiratory pressure (PIP), plateau pressure (Pplat)] measured at 6-12-24h after each administration or randomisation up to 72 hours and then every 24 hours till the patient is discharged from the ICU. - Change from baseline in blood gas analysis acid-base balance parameters (i.e. pH, pCO2, pO2, HCO3, lactate) measured at 6-12-24h after each administration or randomisation up to 72 hours and then every 24 hours till th | — |
Countries
United Kingdom
Outcome results
None listed