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NCT04382391 · ClinicalTrials.gov registry record · NA
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
A NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04382391: Clinical Trial NA study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
NCT04382391 is a NA study that was terminated before completion, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04382391, a NA study, was terminated before completion, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The aims of this study are to summarize and compare the incidence of clinical events and pro-inflammatory cytokine levels in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19. Secondary objectives are demonstrate the safety of gammaCore Sapphire use in patients hospitalized for CoViD-19.
Primary Outcome
compare clinical events between the control group and active group for patients admitted to the hospital for CoViD-19.
Interventions
- DEVICE gammaCore® Sapphire (non-invasive vagus nerve stimulator)
- OTHER Standard of care therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2023-04-13 |
| Phase | NA |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
Why NCT04382391 stopped before completion
NCT04382391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which gammaCore® Sapphire (non-invasive vagus nerve stimulator) is the first listed.
NCT04382391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04382391 about?
NCT04382391 is a clinical study titled "Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms". The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore...
What is the current status of trial NCT04382391?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2020-05-15. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT04382391?
The interventions under investigation include: gammaCore® Sapphire (non-invasive vagus nerve stimulator) (DEVICE), Standard of care therapies (OTHER).
Who is sponsoring clinical trial NCT04382391?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04382391's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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