NCT04341415: SOS-COVID19

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

Terminated NA Last updated 13 April 2021

What this trial tests

NA trial testing Auricular neuromodulation in Covid19 in 31 participants. Terminated before completion.

Timeline

9 April 2020

Primary endpoint
20 November 2020

15 January 2021

Quick facts

Lead sponsor	Fondation Ophtalmologique Adolphe de Rothschild
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	31
Start date	9 April 2020
Primary completion	20 November 2020
Estimated completion	15 January 2021
Sites	2 locations across France

Drugs / interventions tested

• Auricular neuromodulation
• Control

Conditions studied

• Covid19 — all drugs for Covid19 →
• SARS-CoV Infection — all drugs for SARS-CoV Infection →

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild — full company profile →

Who can join

18 and older, any sex, with Covid19 or SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implications for Neuromodulation Therapy to Control Inflammation and Related Organ Dysfunction in COVID-19.
   Fudim M, Qadri YJ, Ghadimi K, MacLeod DB, et al · · 2020 · cited 51× · PMID 32458400 · DOI 10.1007/s12265-020-10031-6
2. The evolving obesity challenge: targeting the vagus nerve and the inflammatory reflex in the response.
   Pavlov VA. · · 2021 · cited 35× · PMID 33310156 · DOI 10.1016/j.pharmthera.2020.107794
3. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
4. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
5. Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study.
   Rangon CM, Barruet R, Mazouni A, Le Cossec C, et al · · 2021 · cited 10× · PMID 34408665 · DOI 10.3389/fphys.2021.704599
6. The role of nicotinic receptors in SARS-CoV-2 receptor ACE2 expression in intestinal epithelia.
   Ten Hove AS, Brinkman DJ, Li Yim AYF, Verseijden C, et al · · 2020 · cited 5× · PMID 33123616 · DOI 10.1186/s42234-020-00057-1
7. The role of nicotinic receptors in SARS-CoV-2 receptor ACE2 expression in intestinal epithelia
   Hove ASt, Brinkman DJ, Yim AYL, Verseijden C, et al · · 2020 · DOI 10.21203/rs.3.rs-46682/v2