Neurotech Firms Seek to Devise COVID-19 Therapies

by James Cavuoto, editor

April 2020 issue

A number of neurotechnology firms and researchers have begun a spirited effort to develop potential treatments for COVID-19. While much of the biomedical research in the U.S. has been oriented toward pharmaceutical and biologics interventions and diagnostics, there are several lines of approach that involve bioelectronic medicine.

One neurotech firm taking a leading role in this effort is electroCore, Inc., the Basking Ridge, NJ bioelectronic medicine company. The company announced 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 Carlos Tornero, head of the anesthesiology-resuscitation department, Hospital Clínico Universitario de Valencia.

Several U.S. 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 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 Staats, CMO 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.”

Staats and colleagues recently published a paper, “Use of Non-Invasive Vagus Nerve Stimulation to Treat Respiratory Symptoms Associated with COVID-19: A Theoretical Hypothesis and Early Clinical Experience,” in the journal Neuromodulation: Technology at the Neural Interface.

Another firm responding to the pandemic is Synapse Biomedical. The Ohio firm received Emergency Use Authorization for its TransAeris DPS diaphragm pacing system, to assist in weaning patients off of ventilators for no more than 30 days.

During the COVID-19 pandemic, the surge of patients requiring prolonged mechanical ventilation has put an unprecedented demand on hospital and ICU resources. Even when their primary symptoms have stabilized, these patients are still at risk for developing ventilator-induced diaphragm dysfunction—further prolonging their ventilation.

The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce or avoid VIDD. Models suggest the technology—which recently received CE Mark approval and is under clinical investigation in the U.S.—could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.

“More than 2,000 patients have been successfully treated world-wide with our diaphragm, pacing technologies,” said Anthony Ignagni, president and CEO of Synapse Biomedical. “We welcome the FDA’s leadership in providing this emergency pathway to get our latest TransAeris device into the hands of clinicians so they can help as many COVID-19 patients as possible during this pandemic.”

Lungpacer Medical in Vancouver, BC received a similar EUA from the FDA for its phrenic nerve stimulation system.