SOS-COVID19: Impact of Auricular Vagus Nerve Neuromodulation on COVID-19 Positive Inpatients Outcome

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Terminated

CT.gov ID

NCT04341415

Collaborator

(none)

Enrollment

Locations

Arms

9.2

Actual Duration (Months)

15.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection	Procedure: Auricular neuromodulation Procedure: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.

Actual Study Start Date :

Apr 9, 2020

Actual Primary Completion Date :

Nov 20, 2020

Actual Study Completion Date :

Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Auricular neuromodulation	Procedure: Auricular neuromodulation 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 Other Names: VERUM
Sham Comparator: Control	Procedure: Control 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. Other Names: SHAM

Arm

Intervention/Treatment

Experimental: Auricular neuromodulation

Procedure: Auricular neuromodulation

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

Other Names:

VERUM

Sham Comparator: Control

Procedure: Control

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.

Other Names:

SHAM

Outcome Measures

Primary Outcome Measures

Comparison of the percentage of clinically improved inpatients between D0 and D14 [14 day after intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

Inpatient requiring legal protection
Pregnant or breastfeeding woman
Intensive care inpatient or patient undergoing surgery

Secondary non inclusion criteria :

Unintentional blinding removal.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Simone Veil	Beauvais		France	60000
2	Fondation Adolphe de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Claire-Marie RANGON, Fondation Adolphe de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04341415

Other Study ID Numbers:

CRN_2020_8

First Posted:

Apr 10, 2020

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild

Non-invasive Neuromodulation

Vagus Nerve

Additional relevant MeSH terms:

COVID-19

Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Apr 13, 2021