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Behavioural Intervention

Vagus Nerve Stimulation for CoViD-19 Respiratory Symptoms (SAVIORII Trial)

N/A
Waitlist Available
Led By Tariq Cheema, MD
Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of enrollment up to 3 months post discharge
Awards & highlights

SAVIORII Trial Summary

This trial is designed to compare the effects of gammaCore Sapphire plus standard of care vs. standard of care alone on reducing respiratory distress in patients hospitalized for CoViD-19.

Eligible Conditions
  • Coronavirus
  • Coronavirus Disease
  • Respiratory Failure
  • Respiratory Distress Syndrome
  • Acute Respiratory Distress Syndrome
  • SARS

SAVIORII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a cough, difficulty breathing, or signs of breathing problems like rapid breathing or increased effort to breathe.

SAVIORII Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of enrollment up to 3 months post discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of enrollment up to 3 months post discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
summarize and compare the incidence of clinical events in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19.
Secondary outcome measures
compare clinical improvement in patients randomized to use of gammaCore Sapphire plus standard of care vs standard of care alone in patients hospitalized for CoViD-19.
decrease mortality of CoViD-19 patients
delay onset of ventilation
+2 more

SAVIORII Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: gammaCore Sapphire® (nVNS) plus standard of careExperimental Treatment2 Interventions
Subjects will be administered study treatment with the nVNS device 3 times per day (prophylaxis) and also as needed for acute respiratory symptoms.
Group II: standard of care aloneActive Control1 Intervention
Will receive standard of care therapies to treat CoViD-19 infection and symptoms

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
13,058 Total Patients Enrolled
ElectroCore INCIndustry Sponsor
30 Previous Clinical Trials
2,229 Total Patients Enrolled
Tariq Cheema, MDPrincipal InvestigatorAllegheny Health Network

Media Library

gammaCore® Sapphire (non-invasive vagus nerve stimulator) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04382391 — N/A
Coronavirus Research Study Groups: gammaCore Sapphire® (nVNS) plus standard of care, standard of care alone
Coronavirus Clinical Trial 2023: gammaCore® Sapphire (non-invasive vagus nerve stimulator) Highlights & Side Effects. Trial Name: NCT04382391 — N/A
gammaCore® Sapphire (non-invasive vagus nerve stimulator) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04382391 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room in this study for additional participants?

"The clinicaltrials.gov website does not indicate that this particular trial is currently enrolling patients. Initially posted on May 8th 2020, and most recently updated November 4th 2022, there are no available spots at the moment but 1789 other trials have open recruitment slots."

Answered by AI
~4 spots leftby Mar 2025