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

Carlos Tornero

Status: Completed

Conditions: Covid-19

Treatments: Device: gammaCore® (Vagus nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04368156

SAVIOR

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Control

No Intervention group

Gammacore treatment

Experimental group

Treatment:

Device: gammaCore® (Vagus nerve stimulation)