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NCT06767241
Transcranial Non-invasive Electrical Stimulation of the Vagus Nerve in Hospitalized Moderate-to-severe COVID-19 Patients
NA trial testing Non-invasive auricular vagus nerve stimulation in COVID-19 in 83 participants. Completed in 31 March 2022.
31 December 2021
Quick facts
| Lead sponsor | University of Medicine and Pharmacy "Victor Babes" Timisoara |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 83 |
| Start date | 1 January 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 March 2022 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- Non-invasive auricular vagus nerve stimulation
- Standard Medical Therapy — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
University of Medicine and Pharmacy "Victor Babes" Timisoara
Who can join
Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06767241
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Non-invasive auricular vagus nerve stimulation
Trials testing the same drug.
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Currently open trials in the same condition.
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Other University of Medicine and Pharmacy "Victor Babes" Timisoara trials
Trials by the same sponsor.
- NCT07393984 — Digital Self-Monitoring in Severe Asthma · NA · completed
- NCT06341569 — Physical Therapy Students: Well-being · NA · completed
- NCT06441500 — Oral Health and Dental Caries Prevention Intervention for Children in Romania · NA · recruiting
- NCT06512142 — Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution · enrolling by invitation
- NCT06912139 — Topical Nitroglycerine for Prevention of Radial Artery Spasm · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06767241 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Medicine and Pharmacy "Victor Babes" Timisoara
- Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06767241.
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