electroCore is supporting a clinical study to evaluate the effect of non-invasive electrical vagus nerve stimulation on respiratory symptoms that occur because of COVID-19.
The bioelectronic medicine specialist said on Wednesday that it had finished enrollment for the SAVIOR-1 controlled-trial. The Rockaway, N.J.-based company is working closely with Hospital Clínico Universitario de Valencia in Spain.
SAVIOR-1 is looking at the impact electroCore’s gammaCore Sapphire could have on symptoms that could occur from the virus. The study enrolled 110 patients over 18 years of age with respiratory failure secondary to SARS-CoV-2 infection. The gammaCore Sapphire received Emergency Use Authorization to treat patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow.
Even as the conversation is switching to prevention and vaccination, treating COVID-19 respiratory symptoms is a major part of the medical community, electroCore said. The company pointed out the most downloaded 2020 article in the Journal of Neuromodulation was The Use of Non‐invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated With COVID‐19: A Theoretical Hypothesis and Early Clinical Experience. “
“The concept and article’s popularity not only suggests interest in nVNS and its role in treating breathing difficulties seen in COVID-19 patients but also emphasizes the medical community is still looking for answers that can help address various COVID-19 symptoms,” said Peter S. Staats, MD, CMO of electroCore. “gammaCore Sapphire CV (nVNS) is unique in its ability to be used early in the course of disease, at home or in a healthcare setting. Research should be focused on identifying novel therapies with strong clinical rationale that can be used throughout the course of disease.”
The second generation of gammaCore won FDA clearance in December of 2017 for the treatment of migraines. However, electroCore delayed the launch of the technology until the summer of 2018. The technology is a 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.