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NCT04493242 · ClinicalTrials.gov registry record · Phase 2
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
A Phase 2 study, sponsored by Direct Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT04493242: Completed Phase 2 study, sponsored by Direct Biologics.
NCT04493242 is a Phase 2 study that has completed, run by Direct Biologics. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493242, a Phase 2 study, has completed, sponsored by Direct Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the 60-day mortality rate for IP 15mL as a treatment for COVID-19 associated moderate to severe ARDS compared to placebo. Reducing the mortality rate for hospitalized patients with COVID-19 associated ARDS is a measure of the treatment effect.
Interventions
- BIOLOGICAL ExoFlo
- OTHER Intravenous normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2021-05-22 |
| Phase | Phase 2 |
What the finished NCT04493242 record still lists
NCT04493242 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which ExoFlo is the first listed.
NCT04493242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04493242 about?
NCT04493242 is a clinical study titled "Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS". 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.
What is the current status of trial NCT04493242?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2020-09-24. Estimated completion is 2021-05-22.
What interventions are being tested in trial NCT04493242?
The interventions under investigation include: ExoFlo (BIOLOGICAL), Intravenous normal saline (OTHER).
Who is sponsoring clinical trial NCT04493242?
This trial is sponsored by Direct Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493242's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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