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

Primary Purpose

COVID19, Sepsis or Other Causes, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
LEAF-4L6715
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19, Sepsis or Other Causes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpitaux Universitaires de Strasbourg
  • Institut de cancérologie Strasbourg Europe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4L6715

Arm Description

exploring various doses of LEAF-4L6715

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
all cause mortality

Full Information

First Posted
May 5, 2020
Last Updated
December 15, 2021
Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
LEAF4Life, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04378920
Brief Title
A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe
Collaborators
LEAF4Life, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Sepsis or Other Causes, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4L6715
Arm Type
Experimental
Arm Description
exploring various doses of LEAF-4L6715
Intervention Type
Drug
Intervention Name(s)
LEAF-4L6715
Intervention Description
LEAF-4L6715
Primary Outcome Measure Information:
Title
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
Time Frame
24, 48 and 72 hours
Title
all cause mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Institut de cancérologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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