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

December 15, 2021 updated by: Institut de cancérologie Strasbourg Europe
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe
      • Strasbourg, France, 67000
        • Hopitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: 28 days
28 days
proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
Time Frame: 24, 48 and 72 hours
24, 48 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

LEAF4Life, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

August 24, 2021

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-003
  • 2020-001393-30 (EudraCT Number)
  • 2020-A00900-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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