Poractant Alfa - Curosurf and SARS-COV-19 ARDS (Covid-19)

Summary

Participation Requirements

Description

This is a UK 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. The same evaluation is pla...

This is a UK 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. 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. 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). An additional exploratory cohort of 15 patients in ECMO will be randomised by 3 sites with a ratio 3:2 (i.e. 9 patients in the poractant alfa arm and 6 in the control arm). The control arm population is treated as per Standard of Care (SoC).

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