Clinical trial NCT04408391: Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
Official title: Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid-19
Anosmia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations) with or without anosmia.

Brief summary: To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

Detailed description: Brain mapping of COVID-19 patients with or without anosmia will allow better understanding of the mechanisms leading to the onset of these symptoms and will provide a pathophysiological basis for the therapeutic interventions to improve the clinical prognosis of affected patients.

The study investigators hypothesize that in COVID-19 patients witch anosmia the brain mapping objectified by an MRI examination is modified and that there are functional abnormalities in the brain in these patients.

Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients consulting the CAREB or hospitalized at the Nîmes teaching hospital due to COVID-19 infection (fever, persistent cough, tiredness, shortness of breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste)
* COVID-19 confirmed by RT-PCR and / or chest CT or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations)
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan "with anosmia" group:
* scoring \< 30 on a VAS 0-100 for olfactory ability
* Responding "yes" to question "have you lost your sense of smell in the last few days?"
* Negative result to olfactory test with n-Butanol diluted to 1/1000. "without anosmia" group:
* scoring \< 80 on a VAS 0-100 for olfactory ability
* Responding "no" to question "have you lost your sense of smell in the last few days?"
* Positive result to olfactory test with n-Butanol diluted to 1/16000.

Exclusion Criteria:

* Patient suffering from serious medical problems or hospitalized in an intensive care unit for invasive ventilation or severe dyspnea.
* Patient with neurological (motor, sensitive or cognitive), neuropsychiatric or vascular disorders.
* Patient with a contraindication to MRI (pace maker, claustrophobic patient, metallic heart valve, etc.).
* Patient with a history of rhinological pathology or a sense of smell problem.
* Patient with known neurological, psychiatric or neuroradiological manifestation.The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject is unable to express consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding

Primary outcomes:
measure: Brain regional homogeneity between COVID-19 patients with and without anosmia
timeFrame: Day 0
Secondary outcomes:
measure: Brain regional homogeneity between COVID-19 patients with and without anosmia
timeFrame: Month 3
measure: Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia
timeFrame: Day 0
measure: Fractional anisotropy between COVID-19 patients with and without anosmia
timeFrame: Day 0
measure: Fractional anisotropy between COVID-19 patients with and without anosmia
timeFrame: Month 3
measure: Mean diffusivity between COVID-19 patients with and without anosmia
timeFrame: Day 0
measure: Mean diffusivity between COVID-19 patients with and without anosmia
timeFrame: Month 3
measure: Radial diffusivity between COVID-19 patients with and without anosmia
timeFrame: Day 0
measure: Radial diffusivity between COVID-19 patients with and without anosmia
timeFrame: Month 3
measure: Self-assessed olfactory and gustatory test
timeFrame: Day 0
measure: Self-assessed olfactory and gustatory test
timeFrame: Day 8
measure: Self-assessed olfactory and gustatory test
timeFrame: Month 1
measure: Self-assessed olfactory and gustatory test
timeFrame: Month 2
measure: Ability to detect odor
timeFrame: Day 0
measure: Ability to taste a pinch of sugar
timeFrame: Day 0
measure: Presence of thrombotic and hemorrhagic lesions
timeFrame: Day 0
measure: Presence of thrombotic and hemorrhagic lesions
timeFrame: Month 3
measure: Presence of lesions with hyperintensity
timeFrame: Day 0
measure: Presence of lesions with hyperintensity
timeFrame: Month 3
measure: Projection network analysis of all patients
timeFrame: Day 0
measure: Projection network analysis of all patients
timeFrame: Month 3
measure: Blinded independent component analysis of all patients
timeFrame: Day 0
measure: Blinded independent component analysis of all patients
timeFrame: Month 3
measure: default mode network analysis of all patients
timeFrame: Day 0
measure: default mode network analysis of all patients
timeFrame: Month 3
measure: executive control network analysis of all patients
timeFrame: Day 0
measure: executive control network analysis of all patients
timeFrame: Month 3
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Benjamin Lallemant
role: PRINCIPAL_INVESTIGATOR
References: