Non-invasive Vagus Nerve Stimulation for COVID-19: Results From a Randomized Controlled Trial (SAVIOR I).

Background: Severe coronavirus disease 2019 (COVID-19) is characterized, in part, by an excessive inflammatory response. Evidence from animal and human studies suggests that vagus nerve stimulation can lead to reduced levels of various biomarkers of inflammation. We conducted a prospective randomized controlled study (SAVIOR-I) to assess the feasibility, efficacy, and safety of non-invasive vagus nerve stimulation (nVNS) for the treatment of respiratory symptoms and inflammatory markers among patients who were hospitalized for COVID-19 (ClinicalTrials.

A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial".

Objectives: Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs.