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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: SARS-CoV Infection; Covid19

Treatments: Procedure: Control; Procedure: Auricular neuromodulation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04341415

CRN_2020_8

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups

Auricular neuromodulation

Experimental group

Treatment:

Procedure: Auricular neuromodulation

Control

Sham Comparator group

Treatment:

Procedure: Control