Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS

Covid19 Clinical Trial

Official title: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS

Status Available

Clinical Trial Summary

ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute respiratory distress syndrome (ARDS). This expanded access protocol is an open label study intended to provide ExoFlo to critically ill patients who do not qualify for the Phase III randomized controlled trial (RCT) because they

• Do not meet phase III eligibility criteria at current phase III sites.

• Do meet phase III eligibility criteria but cannot access phase III sites.

• Do not meet phase III eligibility criteria & cannot access phase III sites.

Clinical Trial Description

Objectives:

First, to provide Investigational Medicinal Product (IMP) to patients with COVID-19 associated moderate to severe ARDS who do not qualify for Protocol DB-EF-PHASEIII-0001. Secondarily, to collect safety and efficacy data.

Endpoints:

Primary Endpoint:

1) 60-day All-Cause Mortality

Secondary Endpoints:

1. Incidence of serious adverse events (SAEs).

2. Ventilator-free days (VFDs).

3. Time to discharge.

Exploratory Endpoints:

1. Acute phase reactants: C-reactive protein (CRP), D-dimer, and Ferritin change from Baseline on Days 3, 5, 7, 10, 15, and 29 for subjects who are still hospitalized.

2. Sequential Organ Failure Assessment (SOFA) Score change from Baseline on Days 15, and 29 for subjects who are still hospitalized.

3. Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ratio from pre-infusion baseline (Day 0) to Day 7. PaO2 may be calculated from arterial blood gas (ABG) or imputed from the SpO2 daily.

Number of subjects: ≤200

Phase: Phase II /Expanded Access Protocol for Intermediate Population ;

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Covid19
• Cytokine Release Syndrome
• Cytokine Storm
• Hypoxia

• NCT number: NCT04657458
• Study type: Expanded Access
• Source: Direct Biologics, LLC
• Contact: Bill Arana
• Phone: 1-800-791-1021
• Email: clinicalaffairs@directbiologics.com
• Status: Available