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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378920
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : October 29, 2020
Sponsor:
Collaborator:
LEAF4Life LLC
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) and are receiving artificial respiratory support 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)
Estimated Enrollment : 90 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


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

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
  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


Contacts
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Contact: Valerie SARTORI 368767223 ext 33 v.sartori@icans.eu
Contact: Manon VOEGELIN, PhD 368767360 ext 33 promotion-rc@icans.eu

Locations
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France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Valerie SARTORI    368767223 ext 33    v.sartori@icans.eu   
Contact: Manon VOEGELIN    368767360 ext 33    m.voegelin@icans.eu   
Principal Investigator: Paul Michel MERTES, PhD MD         
Sub-Investigator: Olivier COLLANGE, PhD MD         
Institut de Cancerologie Strasbourg Europe Recruiting
Strasbourg, France, 67033
Contact: Valerie SARTORI    368767223 ext 33    v.sartori@icans.eu   
Contact: Manon VOEGELIN    368767360 ext 33    m.voegelin@icans.eu   
Principal Investigator: Vitaliy CHABAN, MD         
Sponsors and Collaborators
Institut de cancérologie Strasbourg Europe
LEAF4Life LLC
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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: October 29, 2020
Last Verified: October 2020
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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Sepsis
Toxemia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury