Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04657458
Status:
AVAILABLE
Last Update Posted:
2024-02-12
First Post:
2020-12-07
Brief Title:
Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment Expanded Access Protocol for Patients With COVID-19 Associated ARDS
Status:
AVAILABLE
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 PaO2FiO2 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
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 PaO2FiO2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None