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

NCT06767241 | Completed

• 1 other identifier: 10669/14.12.2020
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Rate of ICU admission

  From the date of study enrollment until the documented date of transfer to Intensive Care Unit (ICU), assessed up until 60 days post hospital admission

Secondary Outcomes (3)

• Need for non-invasive ventilatory support

  From the date of study enrollment until hospital discharge or death, assessed up to 60 days post hospital admission

• Need for mechanical ventilation

  From the date of study enrollment until hospital discharge or death, assessed up to 60 days post hospital admission

• Mortality rate

  From the date of study enrollment until hospital discharge, assessed up to 60 days post hospital admission

Study Arms (2)

Non-invasive auricular vagus nerve stimulation

ACTIVE COMPARATOR

Transcranial electrical stimulation of the vagus nerve delivered through the SPERA device on top of the standard care treatment

Device: Non-invasive auricular vagus nerve stimulation; Other: Standard Medical Therapy

Control group

PLACEBO COMPARATOR

Standard of care treatment

Other: Standard Medical Therapy

Interventions

Non-invasive auricular vagus nerve stimulation DEVICE

Non-invasive transcranial direct current auricular vagus nerve stimulation (tDC-aVNS)

Non-invasive auricular vagus nerve stimulation

Standard Medical Therapy OTHER

Standard of care treatment for moderate to severe COVID-19

Control group; Non-invasive auricular vagus nerve stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalization for confirmed SARS-CoV-2 infection
• moderate-to-severe COVID-19 as demonstrated by the presence of typical lesions on the chest CT scan
• increased risk for cytokine storm (CRP\>46mg/L, ferritin\>250ng/mL)

You may not qualify if:

• critically ill patients upon presentation requiring direct admission to ICU

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead

Study Sites (1)

Infectious Diseases and Pulmonology Clinical Hospital Timisoara

Timișoara, Timiș County, 300310, Romania

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cristian Oancea, University Professor, MD, PhD

  University of Medicine and Pharmacy "Victor Babes" Timisoara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Research and Innovation in Precision Medicine of Respiratory Diseases, Department of Pulmonology, University of Medicine and Pharmacy Timisoara

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

RO (1)