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

NCT06640777 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

LEAF-4L6715

LEAF-4L6715: Administration at a dose of 200mg , for up to 10 days every 12 hours for the first 2 days, followed by once-a-day dosing for the next 8 days (days 3 through 10).

DRUG

Supportive Care

Supportive care, as considered necessary by the treating physician/Principal Investigator (PI), including mechanical ventilation, in line with therapeutic guidelines for ARDS and Multiorgan Failure

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • LEAF4Life, Inc.

    lead INDUSTRY

Principal Investigators

  • Alain Combes, MD · Hôpital de la Pitié Salpêtrière

  • Marie Claude Morice, Ph.D. · CERC - CARDIOVASCULAR EUROPEAN RESEARCH CENTER

  • Clet Niyikiza, Ph.D. · LEAF4Life, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-09
Completion
2027-11-09
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640777 on ClinicalTrials.gov