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

Not Applicable

Terminated

• Conditions: SARS-CoV Infection; Covid19
• Interventions: Procedure: Auricular neuromodulation; Procedure: Control

• Registration Number: NCT04341415
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study Start: 2020-04-09
• Study First Posted: 2020-04-10
• Primary Completion: 2020-11-20
• Study Completion: 2021-01-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular neuromodulation	Auricular neuromodulation	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Centre Hospitalier Simone Veil; 🇫🇷 Beauvais, France

Fondation Adolphe de Rothschild; 🇫🇷 Paris, France