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

NCT06640777 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: LEAF-4L6715-03-01-01
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ARDS

Outcome Measures

Primary Outcomes (2)

• Days free from invasive mechanical ventilation

  From Randomization to Day 30

  30 Days

• 30 Day All-Cause Mortality

  Survival at Day 30

  30 days

Secondary Outcomes (15)

• Mean total of Sequential Organ Failure Assessment (SOFA) score

  30 days

• Need for rescue procedures

  30 days

• Ventilator-associated pneumonia treated with antibiotics between randomization and 30 days.

  30 days

• Number of days alive without organ failure at 30 days and 60 days

  60 days

• Mean reduction in the WHO 9-point Ordinal Scale score

  30 days

Study Arms (2)

LEAF-4L6715 (Liposomal Transcrocetin) + Supportive Care

EXPERIMENTAL

LEAF-4L6715 administered Intravenously 200 mg every 12h for 2 days, then 200 mg Intravenously every 24 hours for 8 days (total 10 days dosing) 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

Drug: LEAF-4L6715; Drug: Supportive Care

Supportive Care

ACTIVE COMPARATOR

Description: 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

Drug: Supportive Care

Interventions

LEAF-4L6715 DRUG

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).

Also known as: Liposomal transcrocetin

LEAF-4L6715 (Liposomal Transcrocetin) + Supportive Care

Supportive Care DRUG

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

LEAF-4L6715 (Liposomal Transcrocetin) + Supportive Care; Supportive Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included if all of the following criteria are met:
• Patients ≥18 years old
• Signed and dated informed consent from patient's trusted person before any study related procedures, pursuing patient signature as soon as patient health condition allows
• ARDS with a documented Positive End-Expiratory Pressure (PEEP) ≥5 and PaO2/FiO2 ratio of ≤200 mm Hg for a minimum of 24 hours prior to randomization
• Patient with an endotracheal tube or tracheostomy tube and receiving MV support
• Life expectancy of at least 24 hours from randomization
• Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) \< 3 x upper limit of normal at the time of randomization
• Male or non-pregnant female patient
• Affiliated to a social security system (for France)

You may not qualify if:

• Enrolled in any other therapeutic clinical trial or receiving an experimental drug (only observational studies allowed)
• Hypersensitivity to crocetins, LEAF 4L6715 or any of its excipients.
• Receiving extracorporeal membrane oxygenation (ECMO) treatment
• On MV for more than 7 days
• Chronic Obstructive Pulmonary Disease (COPD) or other respiratory insufficiency with home ventilation or oxygen therapy
• Severe underlying pre-existing condition with expected 6 months mortality \>50% or survival \<50%
• Patient moribund, decision to limit therapeutic interventions
• Unwilling or unable to comply with study procedures
• Under guardianship, curatorship or safeguard of justice (for France)

Sponsors & Collaborators

• LEAF4Life, Inc.: lead
• European Cardiovascular Research Center: collaborator

Study Sites (1)

Sorbonne University

Paris, Paris, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alain Combes, MD

  Hôpital de la Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

• Marie Claude Morice, Ph.D.

  CERC - CARDIOVASCULAR EUROPEAN RESEARCH CENTER

  STUDY DIRECTOR

• Clet Niyikiza, Ph.D.

  LEAF4Life, Inc.

  STUDY CHAIR

Central Study Contacts

Ute Windhovel, Ph.D.

CONTACT

(609) 2168944; uwindhovel@cerc-europe.org

Solenne Paiva, Ph.D.

CONTACT

spaiva@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, international, multicenter, open label, randomized, controlled, two-arm study.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): November 9, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)