Clinical trial NCT04341415: Impact of Auricular Vagus Nerve Neuromodulation on COVID-19 Positive Inpatients Outcome
Official title: Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
SARS-CoV Infection
Keywords: Non-invasive Neuromodulation
Vagus Nerve
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-04-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the percentage of clinically improved inpatients between D0 and D14
timeFrame: 14 day after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beauvais
country: France
facility: Centre Hospitalier Simone Veil
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
Study officials:
affiliation: Fondation Adolphe de Rothschild
name: Claire-Marie RANGON
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.