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”

AbstractObjectivesPrimary 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 ventilationTrial designThe 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. standard of care alone (SoC) - the control group. The gammaCore® treatments will be used acutely and prophylactically. The active and control groups will be matched for disease and severity.Participantsi. Inclusion CriteriaThe subjects have to meet all of the following criteria to be eligible to enter the trial:Patient older than 18 yearsBeen tested positive or suspected/presumed positive for CoViD-19Has a cough, shortness of breath or respiratory O2 Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failureAgree to use the gammaCore ®-Sapphire device as intended and to follow all of the requirements of the study including recording required ...
Source: Trials - Category: Research Source Type: clinical trials