Clinical trial NCT04405986: Exploring Brain Damages After COVID-19 Infection
Official title: Exploring Brain Damages After COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV 2
Keywords: COVID-19
Brainstem
Electrophysiology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although direct evidence is currently lacking, the high identity between SARS-CoV-1 and SARS-CoV-2 suggests, that the latter viral strain could also infect the Central Nervous System (CNS). Indeed, some cases of SARS-COV2 encephalitis begin to be described and CNS damages are increasingly highlighted in the literature, but still not objectified by imaging and do not allow to explain the entire clinical patterns. We hypothesise that these CNS damages are not always objectified by Magnetic Resonance Imaging (MRI) but could be indirectly observed by a physiological dysfunction of neural conduction in the brainstem. We will explore brainstem disruption through an electrophysiological approach.

Detailed description: Clinical and preclinical data from studies with other coronaviruses suggest an evident neurotropism, which may result in more complex clinical scenarios. Can the SARS-CoV-2 enter the Central Nervous System (CNS) and infect neural cells ? And if yes, how the CNS damage contributes to pathophysiology of the COVID-19, to its signs, symptoms and progression as well as to its sequelae. It has been demonstrated that coronaviruses such as SARS-CoV and MERS-CoV do not limit their presence to the respiratory tract and frequently invade the CNS. The intranasal administration of SARS-CoV-1 or MERS-COV resulted in the rapid invasion of viral particles into the brain of mice, possibly through the olfactory bulb via trans-synaptic route. The brainstem, which hosts the respiratory neuronal circuit in the medulla, was severely infected with both types of viruses, which may contribute to degradation and failure of respiratory centres.

Eligibility criteria: Inclusion Criteria :

* Age ≥ 18 years.
* Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan (CTscan) with specific lesions

Exclusion Criteria :

* History of neurological damage interfering with auditory evoked potentials (PEA) and Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII, etc.)
* Impaired alertness
* Sedative treatments or treatments that disturb nerve conduction.
* Pregnancy or breastfeeding
* Individuals under legal protection or unable to express personally their consent

Primary outcomes:
measure: Latency of electrophysiological response
timeFrame: Inclusion (T0)
measure: Delay of Muscle contraction
timeFrame: Inclusion (T0)
measure: Delay of silent period
timeFrame: Inclusion (T0)
measure: Duration of silent period
timeFrame: Inclusion (T0)
measure: Inhibition rate
timeFrame: Inclusion (T0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: bertrand.glize@chu-bordeaux.fr
name: Bertrand Glize
role: PRINCIPAL_INVESTIGATOR
References: