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

April 8, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Beauvais, France, 60000
        • Centre Hospitalier Simone Veil
      • Paris, France, 75019
        • Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the percentage of clinically improved inpatients between D0 and D14
Time Frame: 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.
14 day after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 9, 2020

Primary Completion (ACTUAL)

November 20, 2020

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRN_2020_8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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