drugset / Trial / NCT06640777
Efficacy and Safety of LEAF-4L6715 for Acute Respiratory Distress Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEAF-4L6715 | Unknown | 200 mg | Intravenous |