Benzinga | Sep 29, 2021 08:18AM EDT

electroCore Announces Open Access And Submission Of Manuscript From SAVIOR-1 Study Of Non-Invasive Vagus Nerve Stimulation (nVNS) In Hospitalized COVID-19 Patients

electroCore, Inc. (NASDAQ:ECOR), a commercial-stage bioelectronic medicine company, today announced that the original author manuscript from the SAVIOR-1 study; a prospective, randomized, controlled study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore SapphireTM in patients admitted to the hospital for treatment of COVID-19; is available on MedRxiv and has been submitted for peer review. This study was an investigator-initiated trial conducted at the Hospital Cl?nico Universitario de Valencia, Spain.



The SAVIOR-1 study enrolled 110 patients over 18 years of age between April 2020 and February 2021. A total of 97 patients comprised of 47 treatment subjects and 50 control subjects provided baseline demographic and medical history data. The study was designed to evaluate the safety and feasibility of nVNS when administered in addition to the then-standard of care in patients hospitalized with active SARS-CoV-2 infection compared with standard of care alone.

The analyses identified significant treatment differences for certain biomarkers of inflammation. Decreases from baseline in C-reaction protein (CRP) levels were significantly greater for the nVNS treatment group as compared to the control group throughout the five-day period combined (p= 0.010) and on day 5 compared to the day 1 baseline period alone (p= 0.012). At day 1, CRP levels were highly elevated for 90% of all subjects, but by days 3 and 5, the percentage of subjects with normal CRP levels improved markedly in the nVNS group with day 3 CRP levels at 17.9% vs. 52.2% in the control (p=0.010). Additionally, the nVNS group had a significantly greater decrease from baseline in procalcitonin level at day 5 (p=0.004) as compared to the control group. Increased levels of CRP, procalcitonin and d-dimer have all been reported to be associated with more severe disease and the lower levels of these markers in the nVNS treated group may represent the initial impact of nVNS therapy to potentially improve the course of a patients' COVID-19 symptoms.

nVNS was well tolerated with no major device related adverse events and the therapy was administered three times daily on most patients as outlined in the study protocol.

The principal investigator of the study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Cl?nico Universitario de Valencia, Spain, commented, "Our results suggest that nVNS may contribute to our efforts in combating the ongoing COVID-19 disease process and its long-term effects through the modulation of biomarkers that are typically associated with a more severe prognosis."

"The ability of nVNS to potentially affect the progression of COVID-19 in these hospitalized patients is encouraging." said Dr. Peter Staats, Chief Medical Officer of electroCore. "As the pandemic continues to evolve, we believe that nVNS could be an appropriate treatment for patients suffering from the long-term effects of COVID-19 by helping combat the increased levels of inflammation."

The manuscript is available at: https://www.medrxiv.org/content/10.1101/2021.09.24.21264045v1