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LEAF-4L6715 in ARDS
NCT04378920Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2020
- Primary completion
- Aug 2021
- Countries
- 1
- Sponsor
- Institut de cancérologie Strasbourg Europe
- Modality
- Small Molecules
- Conditions
- acute respiratory distress syndrome (ARDS)
01
Overview
Phase 2, open-label, single-arm trial of trans sodium crocetinate in acute respiratory distress syndrome (ARDS), sponsored by Institut de cancérologie Strasbourg Europe. Primary endpoint: Proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio at 24 hours. Started Apr 2020; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
4L6715
Patients receiving LEAF-4L6715 at various doses
03
Who it enrols
Adult patients with ARDS (PaO2/FiO2 < 200 mmHg) under artificial ventilation, with normal liver function and adequate hematological parameters. Excludes pregnant/breastfeeding patients, those on ECMO, or with hemoglobinopathy.
04
Endpoints
Primary
Proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Secondary
Proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
All cause mortality
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