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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378920
• Other study ID #: 2020-003
• Secondary ID: 2020-001393-3020
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 14, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: December 2021
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• COVID19, Sepsis or Other Causes
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Syndrome
• Toxemia

Intervention

Drug:
• LEAF-4L6715
LEAF-4L6715

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	LEAF4Life, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio		24 hours
Secondary	proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg		24, 48 and 72 hours
Secondary	all cause mortality		28 days