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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 belowSelect...
You have a cough, difficulty breathing, or signs of breathing problems like rapid breathing or increased effort to breathe.
SAVIORII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of enrollment up to 3 months post discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of enrollment up to 3 months post discharge
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 moreSAVIORII 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have cancer or have recently received cancer treatment.You have a cough, difficulty breathing, or signs of breathing problems like rapid breathing or increased effort to breathe.You are currently using gammaCore® for another medical condition.You have a history of brain-related conditions like aneurysms, bleeding in the brain, brain tumors, or serious head injuries.You have high or low blood pressure, or a slow or fast heartbeat that is considered significant by the doctor.You have metal implants in your neck or near the area where the gammaCore® device will be used.
Research Study Groups:
This trial has the following groups:- Group 1: gammaCore Sapphire® (nVNS) plus standard of care
- Group 2: standard of care alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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