Transcranial Non-invasive Electrical Stimulation of the Vagus Nerve in Hospitalized Moderate-to-severe COVID-19 Patients

Subtle Pulse Electro-biological Recovery Apparatus (SPERA) is an innovative device which delivers digital subliminal pulse stimulation trans cranially to auricular branches of the central nervous system and modulates the anti-inflammatory reflexes mediated by afferent and efferent fibers of the Vagus Nerve. The aim of this single center, interventional study was to assess the efficacy and safety of non-invasive trans-cranial Direct Current auricular Vagus Nerve Stimulation (aVNS) delivered by SPERA in the resolution of inflammatory insults in patients with SARS-CoV-2 infection. Patients hospitalized with moderate-to-severe COVID-19 will be enrolled in the study. Inclusion criteria: RT-PCR confirmed SARS-CoV-2 infection, lung involvement as demonstrated by chest CT scan, increased risk for cytokine storm (CRP\>46mg/L, ferritin\>250ng/mL). Key exclusion criteria: critical patients upon admission, requiring ICU care. SPERA therapy will be administered on top of the standard of care treatment for consecutive patients satisfying the above mentioned criteria.