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

NCT04378920 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: 2020-0032020-001393-302020-A00900-39
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID19, Sepsis or Other Causes; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio

  24 hours

Secondary Outcomes (2)

• proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg

  24, 48 and 72 hours

• all cause mortality

  28 days

Study Arms (1)

4L6715

EXPERIMENTAL

exploring various doses of LEAF-4L6715

Drug: LEAF-4L6715

Interventions

LEAF-4L6715 DRUG

LEAF-4L6715

4L6715

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• LEAF4Life, Inc.: collaborator

Study Sites (2)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

COVID-19; Sepsis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: April 14, 2020
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)