Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

NCT04368156 | Completed FDA Device

• 1 other identifier: SAVIOR
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

Gammacore treatment

EXPERIMENTAL

Device: gammaCore® (Vagus nerve stimulation)

Interventions

gammaCore® (Vagus nerve stimulation) DEVICE

Vagus nerve stimulation using the gammacore neurostimulation device

Gammacore treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carlos Tornero: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (36)

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MeSH Terms

Conditions

COVID-19

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 29, 2020
• Study Start: April 20, 2020
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

ES (1)