This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.
Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing. Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
LEAF-4L6715
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Institut de cancérologie Strasbourg Europe
Strasbourg, France
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Time frame: 24 hours
proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
Time frame: 24, 48 and 72 hours
all cause mortality
Time frame: 28 days
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