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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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04378920
Study type Interventional
Source Institut de cancérologie Strasbourg Europe
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 14, 2020
Completion date August 24, 2021
View Details
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