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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 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.

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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.

Interventions

  • DEVICE gammaCore® Sapphire (non-invasive vagus nerve stimulator)
  • OTHER Standard of care therapies

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2020-05-15
Est. Completion 2023-04-13
Phase NA

What the Registry Record Tells You About NCT04382391

The ClinicalTrials.gov registry entry for NCT04382391 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which gammaCore® Sapphire (non-invasive vagus nerve stimulator) is the first listed.

NCT04382391 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.