clinical trial · NCT04493242
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
Direct Biologics, LLC·phase2·completed·n = 102
COVID-19ARDSExoFloIntravenous normal saline
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.
started
Sep 24, 2020
primary completion
May 1, 2021
completion
May 22, 2021
last updated
Feb 13, 2024
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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol