Trials / Completed
CompletedNCT04493242
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Direct Biologics, LLC · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ExoFlo | Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles |
| OTHER | Intravenous normal saline | Placebo |
Timeline
- Start date
- 2020-09-24
- Primary completion
- 2021-05-01
- Completion
- 2021-05-22
- First posted
- 2020-07-30
- Last updated
- 2024-02-13
- Results posted
- 2023-04-11
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04493242. Inclusion in this directory is not an endorsement.