Vagus Nerve Stimulation ARDS Prevention Trial for COVID-19 Hospitalized Patients

NCT04379037 | Completed

• 1 other identifier: NCM-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to determine if the inflammation modulating effect of vagus nerve stimulation can improve pulmonary function and limit progression to ARDS in hospitalized COVID-19 hospitalized patients.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

vagus nerve stimulation; COVID-19; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Survival without need of mechanical ventilation

  Survival

  Day 14 since symptom onset

• Cumulative incidence of successful tracheal extubation at day 14 since symptom onset.

  Successful tracheal extubation

  Day 14 since symptom onset

Secondary Outcomes (2)

• Survival at day 14 of hospitalization

  Day 14

• Duration of hospitalization

  Day 28

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Adults over 18 years of age hospitalized because of COVID-19 infection will be treated with transcutaneous auricular vagus nerve stimulation (taVNS).

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

Transcutaneous vagus nerve stimulation involves stimulating the auricular branch of the vagus nerve with a imperceptible electrical current within the concha of the ear.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Patients who are 18 years of age
• Tested positive or suspected/presumed positive for COVID-19 infection
• Patients requiring hospital admission moderate to severe pneumonia and pneumopathy
• Patients showing fever and respiratory symptoms with radiological findings of pneumonia
• Respiratory distress (≧30 breaths/ min) or Oxygen saturation ≤93% at rest in ambient air; or oxygen saturation ≤97 % with O2 \> 5L/min
• Patient is able to provide signed and witnessed Informed Consent

You may not qualify if:

• Already enrolled in a trial for COVID-19 therapy
• Potentially life threatening heart rhythm
• Pregnancy or potential pregnancy
• Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
• History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma
• Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner)

Sponsors & Collaborators

• Nemechek Technologies: lead

Study Sites (1)

Hospital Zonal Virgen del Carmen de Zárate

Zárate, Buenos Aires, B2800DDF, Argentina

Location

Related Publications (4)

• Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

  PMID: 32192578 BACKGROUND

• Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9;13:854. doi: 10.3389/fnins.2019.00854. eCollection 2019.

  PMID: 31447643 BACKGROUND

• Tanaka S, Hammond B, Rosin DL, Okusa MD. Neuroimmunomodulation of tissue injury and disease: an expanding view of the inflammatory reflex pathway. Bioelectron Med. 2019 Aug 13;5:13. doi: 10.1186/s42234-019-0029-8. eCollection 2019.

  PMID: 32232102 BACKGROUND

• Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

  PMID: 32217835 BACKGROUND

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

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; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objective of this study is to determine the therapeutic effect of transcutaneous vagus nerve stimulation in patients with moderate, severe or critical pneumonia associated with Coronavirus Disease 2019 (COVID-19).

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: June 27, 2020
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)