Skip to main content
OpenTrials
Completed

NCT Number: NCT04368156

Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gammaCore® (Vagus nerve stimulation)

Device

Vagus nerve stimulation using the gammacore neurostimulation device

Primary outcomes

  1. Incidence of changes in specific clinical events in patients with covid-19.

    Time frame: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months

    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

Sponsors and collaborators

Lead sponsor

Carlos Tornero

Other

Registry information

Official study title

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

Acronym: SAVIOR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2020
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.