electroCore Announces Completion of Enrollment in SAVIOR-1 Study of Non-Invasive Vagus Nerve Stimulation (nVNS) in COVID-19 Patients Exhibiting Respiratory Symptoms
ROCKAWAY, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the completion of patient enrollment in
SAVIOR-1, a prospective, randomized, controlled study evaluating vagus nerve stimulation in patients who exhibit respiratory symptoms due to COVID-19. This study is being conducted at the Hospital
Clínico Universitario de Valencia, Spain.
The SAVIOR-1 study enrolled 110 patients over 18 years of age with respiratory failure secondary to SARS-CoV-2 infection. The study is designed to evaluate the incidence of relevant clinical events in patients with active SARS-CoV-2 infection. Study subjects were randomized to either the study group receiving non-invasive vagus nerve stimulation (nVNS; gammaCore Sapphire) together with conventional treatment, or the control group receiving conventional treatment alone. The study is also evaluating the safety of gammaCore Sapphire in patients hospitalized for COVID-19, in addition to the blood levels of proinflammatory cytokines in these patients. Preliminary results will be reported once available and full results will be published in a peer-reviewed scientific journal later this year.
The principal investigator of the study, Dr. Carlos Tornero, Head of the Department of Anesthesiology, Resuscitation and Pain Therapeutics of the Hospital Clínico Universitario de Valencia, Spain, commented, "We are very pleased to have successfully completed the enrollment of patients in this trial evaluating the clinical benefit of nVNS in patients suffering from COVID-19 respiratory distress. We look forward to seeing the data from this study in the hope that nVNS may provide clinical benefit to many of those suffering from COVID-19."
"The ability of nVNS to decrease respiratory distress, and possibly limit inflammatory cytokine levels, has previously been demonstrated in several preclinical models. This preclinical work provided the basis for studying nVNS in COVID-19 patients suffering respiratory distress," said Dr. Peter Staats, Chief Medical Officer of electroCore.
Complete details on the study design can be found at the following link: NCT04368156
gammaCore (nVNS) is the first non-invasive manual medical therapy delivered to the neck as adjunctive therapy to treat migraine and cluster headache using mild electrical stimulation of the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed medications. When placed on the patient's neck over the vagus nerve, gammaCore stimulates afferent nerve fibers, which can lead to a reduction in pain for patients.