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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 is a Phase 2 study that has completed, run by Direct Biologics. The registered enrollment target is 102 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493242
The ClinicalTrials.gov registry entry for NCT04493242 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Direct Biologics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ExoFlo is the first listed.
NCT04493242 reports 0 study locations.
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.
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