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

Sponsor

Institut de cancérologie Strasbourg Europe (Other)

Overall Status

Completed

CT.gov ID

NCT04378920

Collaborator

LEAF4Life, Inc. (Other)

Enrollment

Locations

Arm

16.3

Actual Duration (Months)

18.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID19, Sepsis or Other Causes Acute Respiratory Distress Syndrome	Drug: LEAF-4L6715	Phase 1/Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 14, 2020

Actual Primary Completion Date :

Aug 24, 2021

Actual Study Completion Date :

Aug 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4L6715 exploring various doses of LEAF-4L6715	Drug: LEAF-4L6715 LEAF-4L6715

Arm

Intervention/Treatment

Experimental: 4L6715

exploring various doses of LEAF-4L6715

Drug: LEAF-4L6715

LEAF-4L6715

Outcome Measures

Primary Outcome Measures

proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio [24 hours]

Secondary Outcome Measures

proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg [24, 48 and 72 hours]
all cause mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)