Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms

Covid-19 Clinical Trial

— SAVIOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368156
• Other study ID #: SAVIOR
• Status: Completed
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: February 17, 2021

Study information

• Verified date: January 2022
• Source: Hospital Clínico Universitario de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Signs and Symptoms, Respiratory

Intervention

Device:
• gammaCore® (Vagus nerve stimulation)
Vagus nerve stimulation using the gammacore neurostimulation device

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Carlos Tornero

Country where clinical trial is conducted

Spain, 

References & Publications (34)

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Lerman I, Hauger R, Sorkin L, Proudfoot J, Davis B, Huang A, Lam K, Simon B, Baker DG. Noninvasive Transcutaneous Vagus Nerve Stimulation Decreases Whole Blood Culture-Derived Cytokines and Chemokines: A Randomized, Blinded, Healthy Control Pilot Trial. Neuromodulation. 2016 Apr;19(3):283-90. doi: 10.1111/ner.12398. Epub 2016 Mar 15. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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