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Saturday, July 18, 2020 5:57:51 PM
"Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)"
Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborator:
ElectroCore INC
Information provided by (Responsible Party):
Tariq Cheema, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care (active) vs. standard of care alone (SoC), the control group. The gammaCore® (nVNS) treatments will be used acutely and prophylactically. The active and control groups will be diseased and severity matched.
The primary objective is to reduce initiation of mechanical ventilation in patients with CoViD-19 compared to the control group. Secondary objectives are to evaluate cytokine trends/prevent cytokine storms, evaluate supplemental oxygen requirements, decrease mortality of CoViD-19 patients and to delay the onset of mechanical ventilation.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, Controlled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII)
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : September 1, 2020
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