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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368156
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Carlos Tornero, Hospital Clínico Universitario de Valencia

Study Description
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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

Condition or disease Intervention/treatment Phase
Covid-19 Device: gammaCore® (Vagus nerve stimulation) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : February 17, 2021
Actual Study Completion Date : February 17, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Experimental: Gammacore treatment Device: gammaCore® (Vagus nerve stimulation)
Vagus nerve stimulation using the gammacore neurostimulation device


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368156


Locations
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Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Carlos Tornero
More Information
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Additional Information:

Publications:
1 Staats, P., et al. (2018). In E.Krames, et. al (Eds.) Neuromodulation : Comprehensive Textbook of Principles, Technologies, and Therapies Vol 1: Neurostiumulation for Asthma (2nd Edition, pp. 1339-1345). London, United Kingdom: Academic Press, Elsevier.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carlos Tornero, Doctor, Hospital Clínico Universitario de Valencia
ClinicalTrials.gov Identifier: NCT04368156    
Other Study ID Numbers: SAVIOR
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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COVID-19
Signs and Symptoms, Respiratory
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases