Clinical trial NCT04368156: Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
Official title: A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Lead sponsor: Hospital Clínico Universitario de Valencia
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Incidence of changes in specific clinical events in patients with covid-19.
timeFrame: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References:
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