Subtle Pulse Electro-biological Recovery Apparatus (SPERA) for COVID-19 - a Proof of Concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Rate of ICU admission
Study Overview
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.
Detailed Description
Can non-invasive transcranial Direct Current Auricular Vagus Nerve Stimulation (tDC-aVNS) inhibit Cellular and Systemic Inflammation in COVID-19, reducing risk of longer hospitalization, chronic morbidity and mortality?
A clinical research protocol to determine if non-invasive trans-cranial Direct Current auricular Vagus Nerve Stimulation (tDC-aVNS) decreases pro-inflammatory Cytokines and Chemokines in COVID-19: a Proof of Concept Trial of adults with moderate to severe symptomology, at greatest danger of SARS-Cov2 Cytokine Storm.
Objectives:
To observe how many patients with moderate-severe forms of Covid-19 will need to be admitted to the ICU with hyper-inflammation (Cytokine Storm) after application of Subtle Pulse Electro-biological Recovery Apparatus (SPERA) in addition to the Standard of Care (SOC), comparing tDC-aVNS from Prescription group and a Control group who receive only SOC.
SOC observations for all patients will include: a CT scan prior to admission or in the first days after admission. Blood samples collected for hemoleucogram with FBC, coagulation parameters, D-dimers, fibrinogen, CRP, procalcitonin, LDH, ferritin, ALT, AST, urea, creatinine, glucose, sodium, potassium, GGT, bilirubin. The clinical status (symptoms and clinical signs) will be checked daily and the vital signs: BP, pulse rate, temperature, oxygen saturation will also be measured regularly. An ECG will be routinely performed and cardiologist's advice will be sought on anticoagulation treatment. Additional investigations will be performed upon request as needed (such as inflammatory cytokines, etc). Further objective measures will include: time to clinical recovery, clinical status, hospital length of stay, number of days with supplemental oxygen and/or non-invasive ventilation, mortality rate.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •critically ill patients upon presentation requiring direct admission to ICU
Outcomes
Primary Outcomes
Rate of ICU admission
Time Frame: 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
- 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)
Investigators
Basaraba Gabriela Lavinia
Center for Research and Innovation in Precision Medicine of Respiratory Diseases, Department of Pulmonology, University of Medicine and Pharmacy Timisoara
University of Medicine and Pharmacy "Victor Babes" Timisoara