A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes

Inclusion Criteria:

1. Signed informed consent from the patient or patient's legal representative must be
obtained prior to any procedures, as the likelihood of patients being able to provide
consent is very limited

2. Patients must be ≥ 18 years old

3. Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2
ratio of less than 200 mm Hg

4. Patient must be under artificial ventilation support (including patient under
OptiflowTM Nasal High Flow device or an equivalent device)

5. Patient must have a life expectancy of at least 24 hours

6. Patients should have normal liver function as defined by ALT, AST and alkaline
phosphate less than 3 ULN for the institution

7. Patient must have platelet count above >100,000 cells/mm3, hemoglobin > 8 g/dL and an
absolute neutrophil count (ANC) of > 1000 cells/mm3

8. Patients requiring dialysis due to renal impairment in cohort 3

Exclusion Criteria:

1. Patient is enrolled in any other therapeutic clinical trial with the same endpoints.
All observational studies or study with limited invasive methods (Pharmacokinetic
studies, monitoring of virus charges studies, biological monitoring studies ….) are
allowed

2. Patient is pregnant or breast-feeding

3. Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its
excipients

4. Patients with hemoglobinopathy

5. Patients receiving extracorporeal membrane oxygenation (ECMO)