Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

Study Overview
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Brief Summary
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The purpose of this study is to asses the efficacy of the Gammacore device reducing the need for mechanical ventilation in patients diagnosed of Covid-19

Official Title
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A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)

Conditions
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Covid-19

Intervention / Treatment
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* Device: gammaCore® (Vagus nerve stimulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has been tested positive or suspected/presumed positive for CoViD-19 Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.) O2 Saturation less than or equal to 96% on room air or sensation Agrees to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data Patient is able to provide signed and witnessed Informed Consent Exclusion Criteria: On home/therapy oxygen (i.e. for COPD patients) at baseline prior to development of CoViD-19 Is already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-19 Already gammaCore for other medical conditions A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction Uncontrolled high blood pressure (>140/90) Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) Compromised access to peripheral veinous for blood) Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Gammacore treatment<br> | Device: gammaCore® (Vagus nerve stimulation)<br>* Vagus nerve stimulation using the gammacore neurostimulation device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of changes in specific clinical events in patients with covid-19. | The clinical events include, but are not limited, to: Proportion of subjects requiring mechanical ventilation Days to onset of mechanical ventilation Oxygen support requirements O2 saturation Pain levels PaO2/FiO2 Coagulation Laboratory measurements related to circulating cytokines and inflammation. Live discharge from the hospital Patient length of stay Mortality Need for intensive care Shortness of breath Device related serious adverse events Adverse events | From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months |