Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)

January 28, 2022 updated by: Carlos Tornero

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Has been tested positive or suspected/presumed positive for CoViD-19
  2. Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.)
  3. O2 Saturation less than or equal to 96% on room air or sensation
  4. Agrees to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data
  5. Patient is able to provide signed and witnessed Informed Consent

Exclusion Criteria:

  1. On home/therapy oxygen (i.e. for COPD patients) at baseline prior to development of CoViD-19
  2. Is already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-19
  3. Already gammaCore for other medical conditions
  4. A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma
  5. 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
  6. Uncontrolled high blood pressure (>140/90)
  7. 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
  8. Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site
  9. 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)
  10. Compromised access to peripheral veinous for blood)
  11. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Gammacore treatment
Device: gammaCore® (Vagus nerve stimulation)
Vagus nerve stimulation using the gammacore neurostimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos Tornero

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2020

Primary Completion (ACTUAL)

February 17, 2021

Study Completion (ACTUAL)

February 17, 2021

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAVIOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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