Impact of Auricular Vagus Nerve Neuromodulation on COVID-19 Positive Inpatients Outcome

NCT04341415 | Terminated

• 1 other identifier: CRN_2020_8
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

Conditions

Covid19; SARS-CoV Infection

Keywords

Non-invasive Neuromodulation; Vagus Nerve

Outcome Measures

Primary Outcomes (1)

• Comparison of the percentage of clinically improved inpatients between D0 and D14

  Inpatients are considered as clinically improved if they have gained at least 2 points on the following clinical evaluation scale, or if they went back home Clinical evaluation scale :1. Outpatient back to normal activities / 2. Outpatient without normal activities / 3. Inpatient without oxygen therapy / 4. Inpatient with oxygen therapy/ 5. Inpatient requiring either nasal high-flow oxygen therapy or non-invasive respirator or both / 6. Inpatient, requiring either ExtraCorporeal Membrane Oxygenation (ECMO) or invasive artificial respirator, or both / 7. Deceased.

  14 day after intervention

Study Arms (2)

Auricular neuromodulation

EXPERIMENTAL

Procedure: Auricular neuromodulation

Control

SHAM COMPARATOR

Procedure: Control

Interventions

Auricular neuromodulation PROCEDURE

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room. Ear disinfection and sterile neuromodulation needle placement (service protocol with Chlorhexidine) Placement of 4 semi-permanent Classic needles (SEDATELEC®) on each ear flap at the level of the concha (innervated by the vagus nerve) according to an order and a precise location (4 cardinal points conch), i.e. 8 needles per patient. Compress soaked with Oxygenated water on the concha (to stop potential bleeding). Placing an opaque dressing on the ear and a non-occlusive Band-Aid

Also known as: VERUM

Auricular neuromodulation

Control PROCEDURE

The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room. Ear disinfection and sterile manipulation without needle placement (service protocol with Chlorhexidine) No needle laying but only sterile disinfection and pressure over the 4 putative locations with the sterile plastic tip (without the needle). Compress soaked with Oxygenated water on the concha. Placing an opaque dressing on the ear and a non-occlusive Band-Aid.

Also known as: SHAM

Control

Eligibility Criteria

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

You may qualify if:

• COVID-19 positive inpatient (PCR or other certified test mandatory)
• Inpatient showing at least one of the following criterion: Abnormal respiratory auscultation AND SpO2 \< 94% without oxygen therapy, OR Acute Respiratory failure requiring either oxygen therapy or high-flow oxygen therapy or non-invasive respirator and/or invasive respirator.

You may not qualify if:

• Inpatient requiring legal protection
• Pregnant or breastfeeding woman
• Intensive care inpatient or patient undergoing surgery
• \- Unintentional blinding removal.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Centre Hospitalier Simone Veil

Beauvais, 60000, France

Location

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

• Rangon CM, Barruet R, Mazouni A, Le Cossec C, Thevenin S, Guillaume J, Leguillier T, Huysman F, Luis D. Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study. Front Physiol. 2021 Aug 2;12:704599. doi: 10.3389/fphys.2021.704599. eCollection 2021.

  PMID: 34408665 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

salicylhydroxamic acid

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

• Claire-Marie RANGON

  Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants and the care providers will not know the arm of randomization. Only the principal investigator who will perform the intervention will know the type of intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 9, 2020
• Primary Completion: November 20, 2020
• Study Completion: January 15, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

FR (2)