electroCore Provides Update on COVID-19 Clinical Initiatives

Randomized controlled investigator-initiated trial (IIT) of non-invasive vagus nerve stimulation (nVNS) therapy currently enrolling COVID-19 patients in Spain

Peer-reviewed paper, “Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience,” accepted for publication in the journal Neuromodulation: Technology at the Neural Interface   

BASKING RIDGE, N.J., April 27, 2020 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an update on ongoing nVNS COVID-19 initiatives.

The company announced today that an investigator-initiated, randomized, controlled clinical trial of nVNS therapy has commenced enrolling COVID-19 patients in Spain. The trial, “Prospective, Randomized, Controlled Study to Evaluate the Effect of Non-Invasive Electrical Vagus Nerve Stimulation on Respiratory Symptoms due to COVID-19 (SAVIOR),” is designed to assess the ability of nVNS to  decrease the number of hospitalized COVID-19 patients requiring use of a ventilator. In the treatment group, nVNS will be provided in addition to the current standard of care. nVNS will be used prophylactically, three times a day, as well as acutely when needed by patients, with the goal of improving breathing and decreasing the need for mechanical ventilation. The control group will consist of patients matched to the stimulation group in terms of severity and will be treated with standard of care alone. The trial is being led by Dr. Carlos Tornero, M.D., Head of the Anesthesiology-Resuscitation Department, Hospital Clínico Universitario de Valencia.

Multiple US institutions have expressed interest in conducting additional controlled clinical studies of nVNS’ potential utility in treating COVID-19 patients. A second investigator-initiated randomized, controlled trial protocol (SAVIOR-2) was recently approved by the Institutional Review Board (IRB) at one U.S. institution and should commence soon. Additional U.S. investigator-initiated trials are under consideration.

“COVID 19 is causing a worldwide pandemic, the likes of which we have not seen before. Worldwide data indicate that COVID 19 causes a lethal cytokine storm in a small percentage of people who contract the virus, so strategies directed at blocking cytokine release hold promise,” commented Peter S. Staats, MD, Chief Medical Officer of electroCore. “Pre-clinical work and early pilot studies in respiratory indications such as asthma and bronchoconstriction, the ability of nVNS to block cytokine release, and literature demonstrating that VNS blocks the cytokine storm in animals, all support the hypothesis that nVNS may improve outcomes in patients with COVID-19.”