This is a multicentre, open-label, randomized phase II proof of concept study. The efficacy and safety of poractant alfa will be evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients with ARDS due to SARS-COV-19 infection.~Each patient randomized to the study treatment will receive three administrations of Curosurf ® with a 24 hours dosing interval.~The assessment collection will last until day 28 when the evaluation will occur at the ICU, or by phone call if the patient has been discharged before.~Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).~The control arm population is treated as per Standard of Care (SoC).~This study will be conducted in UK, US and Italy.
The purpose of this Phase II -Proof of Concept study is to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in adult hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)