Trial | NCT04378920  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    37
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 Started
Apr 14
2020
Primary Completion
Aug 24
2021
Study Completion
Aug 24
2021
Last Update
Dec 16
2021

Drug LEAF-4L6715

LEAF-4L6715

4L6715 Experimental

exploring various doses of LEAF-4L6715

Criteria 

Inclusion Criteria:

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
Patients must be ≥ 18 years old
Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2 ratio of less than 200 mm Hg
Patient must be under artificial ventilation support (including patient under OptiflowTM Nasal High Flow device or an equivalent device)
Patient must have a life expectancy of at least 24 hours
Patients should have normal liver function as defined by ALT, AST and alkaline phosphate less than 3 ULN for the institution
Patient must have platelet count above >100,000 cells/mm3, hemoglobin > 8 g/dL and an absolute neutrophil count (ANC) of > 1000 cells/mm3
Patients requiring dialysis due to renal impairment in cohort 3

Exclusion Criteria:

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
Patient is pregnant or breast-feeding
Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its excipients
Patients with hemoglobinopathy
Patients receiving extracorporeal membrane oxygenation (ECMO)
No Results Posted