drugset / Trial / NCT06640777

Efficacy and Safety of LEAF-4L6715 for Acute Respiratory Distress Syndrome

NCT06640777 ↗

Phase 3 Not yet recruiting 310 enrolled LEAF4Life, Inc. European Cardiovascular Research Center · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Acute Respiratory Distress Syndrome (ARDS) is a serious condition where people in hospital care suddenly have trouble breathing because of infection, pneumonia, COVID-19 or other disease. People with ARDS may have to be put in an intensive care unit (ICU) and on a ventilator to help them breathe. This trial is to try to find out if injecting a product called LEAF-4L6715 makes the treatment better or worse than what is normally given. LEAF-4L6715 is a product that contains tiny bubbles to slowly release a substance named transcrocetin which scientific studies show may increase oxygen flow and reduce inflamed cells and protect tissues of the body.

Timeline

Start
2024-11-01
Primary completion
2026-11-09
Completion
2027-11-09

Drugs

EvaluationDrugModalityDoseRoute
Subject LEAF-4L6715 Unknown 200 mg Intravenous