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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

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ClinicalTrials.gov Identifier: NCT04378920
Recruitment Status : Completed
First Posted : May 7, 2020
Last Update Posted : December 16, 2021
LEAF4Life, Inc.
Information provided by (Responsible Party):
Institut de cancérologie Strasbourg Europe

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 14, 2020
Actual Primary Completion Date : August 24, 2021
Actual Study Completion Date : August 24, 2021

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

Primary Outcome Measures :
  1. proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg [ Time Frame: 24, 48 and 72 hours ]
  2. all cause mortality [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378920

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Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Sponsors and Collaborators
Institut de cancérologie Strasbourg Europe
LEAF4Life, Inc.
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Responsible Party: Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier: NCT04378920    
Other Study ID Numbers: 2020-003
2020-001393-30 ( EudraCT Number )
2020-A00900-39 ( Other Identifier: IDRCB )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury