Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04493242
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2020-07-29
Brief Title:
Extracellular Vesicle Infusion Treatment for 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 for COVID-19 Associated Acute Respiratory Distress Syndrome ARDS A Phase II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04657458
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
EXIT-COVID19
Brief Summary:
To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles ExoFlo versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome ARDS in patients with severe COVID-19
Detailed Description:
This is a Phase II double-blinded placebo-controlled randomized controlled trial that enrolled 102 subjects that were admitted with COVID-19 associated moderate-to-severe ARDS across 6 sites in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None