Status:
COMPLETED
A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes
Lead Sponsor:
Institut de cancérologie Strasbourg Europe
Collaborating Sponsors:
LEAF4Life, Inc.
Conditions:
COVID19, Sepsis or Other Causes
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 ass...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04378920
Start Date
April 14 2020
End Date
August 24 2021
Last Update
December 16 2021
Active Locations (2)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
2
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033