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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04408391
Other study ID # NIMAO/2020-01/BL-001
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 20, 2020
Est. completion date July 6, 2020

Study information

Verified date August 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 6, 2020
Est. primary completion date July 6, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Brain MRI scan
Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner

Locations

Country Name City State
France CHU de Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain regional homogeneity between COVID-19 patients with and without anosmia MRI; Voxels Day 0
Secondary Brain regional homogeneity between COVID-19 patients with and without anosmia MRI; Voxels Month 3
Secondary Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia MRI; Voxels Day 0
Secondary Fractional anisotropy between COVID-19 patients with and without anosmia MRI; voxels, value between 0-1 Day 0
Secondary Fractional anisotropy between COVID-19 patients with and without anosmia MRI; voxels, value between 0-1 Month 3
Secondary Mean diffusivity between COVID-19 patients with and without anosmia MRI; mm2/s Day 0
Secondary Mean diffusivity between COVID-19 patients with and without anosmia MRI; mm2/s Month 3
Secondary Radial diffusivity between COVID-19 patients with and without anosmia MRI; mm2/s Day 0
Secondary Radial diffusivity between COVID-19 patients with and without anosmia MRI; mm2/s Month 3
Secondary Self-assessed olfactory and gustatory test Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today Day 0
Secondary Self-assessed olfactory and gustatory test Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today Day 8
Secondary Self-assessed olfactory and gustatory test Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today Month 1
Secondary Self-assessed olfactory and gustatory test Four questions measured by 0-100 visual analogue scale: how do you rate the quality of your sense of smell/taste normally/today Month 2
Secondary Ability to detect odor Ability to smell 1.5ml air freshner on a 0-100 VAS scale (cut-offs: strang (>80), moderate (40-80), attenuated (<40) Day 0
Secondary Ability to taste a pinch of sugar Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty Day 0
Secondary Presence of thrombotic and hemorrhagic lesions MRI: absence/presence Day 0
Secondary Presence of thrombotic and hemorrhagic lesions MRI: absence/presence Month 3
Secondary Presence of lesions with hyperintensity Short Ti Inversion Recovery (STIR); presence/absence Day 0
Secondary Presence of lesions with hyperintensity Short Ti Inversion Recovery (STIR); presence/absence Month 3
Secondary Projection network analysis of all patients beta voxels Day 0
Secondary Projection network analysis of all patients beta voxels Month 3
Secondary Blinded independent component analysis of all patients beta voxels Day 0
Secondary Blinded independent component analysis of all patients beta voxels Month 3
Secondary default mode network analysis of all patients beta voxels Day 0
Secondary default mode network analysis of all patients beta voxels Month 3
Secondary executive control network analysis of all patients beta voxels Day 0
Secondary executive control network analysis of all patients beta voxels Month 3
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