Covid-19ANOSIRMNCT04408391
Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
An observational study of Covid-19 and Anosmia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Brain MRI scan
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 6 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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?"
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
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.
Read the 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.
- Being tested
- Brain MRI scan
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI scanOther
Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients with anosmia | Patients reporting loss of smell and scoring < 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000 Receives: Other: Brain MRI scan | |
| COVID-19 patients without anosmia | Patients reporting no loss of smell and scoring > 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000 Receives: Other: Brain MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain regional homogeneity between COVID-19 patients with and without anosmia
MRI; Voxels
Measured: Day 0
Secondary outcomes (26)
Brain regional homogeneity between COVID-19 patients with and without anosmia
MRI; Voxels
Measured: Month 3
Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia
MRI; Voxels
Measured: Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia
MRI; voxels, value between 0-1
Measured: Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia
MRI; voxels, value between 0-1
Measured: Month 3
Mean diffusivity between COVID-19 patients with and without anosmia
MRI; mm2/s
Measured: Day 0
Mean diffusivity between COVID-19 patients with and without anosmia
MRI; mm2/s
Measured: Month 3
Radial diffusivity between COVID-19 patients with and without anosmia
MRI; mm2/s
Measured: Day 0
Radial diffusivity between COVID-19 patients with and without anosmia
MRI; mm2/s
Measured: Month 3
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
Measured: Day 0
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
Measured: Day 8
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
Measured: Month 1
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
Measured: Month 2
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)
Measured: Day 0
Ability to taste a pinch of sugar
Patient asked to describe whether a pinch of sugar on their tongue taste sweet or salty
Measured: Day 0
Presence of thrombotic and hemorrhagic lesions
MRI: absence/presence
Measured: Day 0
Presence of thrombotic and hemorrhagic lesions
MRI: absence/presence
Measured: Month 3
Presence of lesions with hyperintensity
Short Ti Inversion Recovery (STIR); presence/absence
Measured: Day 0
Presence of lesions with hyperintensity
Short Ti Inversion Recovery (STIR); presence/absence
Measured: Month 3
Projection network analysis of all patients
beta voxels
Measured: Day 0
Projection network analysis of all patients
beta voxels
Measured: Month 3
Blinded independent component analysis of all patients
beta voxels
Measured: Day 0
Blinded independent component analysis of all patients
beta voxels
Measured: Month 3
default mode network analysis of all patients
beta voxels
Measured: Day 0
default mode network analysis of all patients
beta voxels
Measured: Month 3
executive control network analysis of all patients
beta voxels
Measured: Day 0
executive control network analysis of all patients
beta voxels
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 May 2020
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Why it stopped: No Inclusion potentiel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408391
- Sponsor's protocol ID
- NIMAO/2020-01/BL-001
- Acronym
- ANOSIRM
- Status last verified
- Aug 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia
- ClinicalTrials.gov ID
- NCT04408391
- Acronym / sponsor ID
- ANOSIRM / NIMAO/2020-01/BL-001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Inclusion potentiel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients with anosmia | – | Other: Brain MRI scanPatients reporting loss of smell and scoring < 30 on a VAS 0-100 for ability to detect n-Butanol diluted 1/1000 |
| COVID-19 patients without anosmia | – | Other: Brain MRI scanPatients reporting no loss of smell and scoring > 80 on a VAS 0-100 for ability to detect n-Butanol diluted 1/16000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRI scanResting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner | Other | COVID-19 patients with anosmia, COVID-19 patients without anosmia |
Primary outcome
Brain regional homogeneity between COVID-19 patients with and without anosmia
Time frame: Day 0
MRI; Voxels
26 secondary outcomes
Brain regional homogeneity between COVID-19 patients with and without anosmia
Time frame: Month 3
Topography of supra- or sub-tentorial lesions between COVID-19 patients with and without anosmia
Time frame: Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia
Time frame: Day 0
Fractional anisotropy between COVID-19 patients with and without anosmia
Time frame: Month 3
Mean diffusivity between COVID-19 patients with and without anosmia
Time frame: Day 0
Mean diffusivity between COVID-19 patients with and without anosmia
Time frame: Month 3
Radial diffusivity between COVID-19 patients with and without anosmia
Time frame: Day 0
Radial diffusivity between COVID-19 patients with and without anosmia
Time frame: Month 3
Self-assessed olfactory and gustatory test
Time frame: Day 0
Self-assessed olfactory and gustatory test
Time frame: Day 8
Self-assessed olfactory and gustatory test
Time frame: Month 1
Self-assessed olfactory and gustatory test
Time frame: Month 2
Ability to detect odor
Time frame: Day 0
Ability to taste a pinch of sugar
Time frame: Day 0
Presence of thrombotic and hemorrhagic lesions
Time frame: Day 0
Presence of thrombotic and hemorrhagic lesions
Time frame: Month 3
Presence of lesions with hyperintensity
Time frame: Day 0
Presence of lesions with hyperintensity
Time frame: Month 3
Projection network analysis of all patients
Time frame: Day 0
Projection network analysis of all patients
Time frame: Month 3
Blinded independent component analysis of all patients
Time frame: Day 0
Blinded independent component analysis of all patients
Time frame: Month 3
default mode network analysis of all patients
Time frame: Day 0
default mode network analysis of all patients
Time frame: Month 3
executive control network analysis of all patients
Time frame: Day 0
executive control network analysis of all patients
Time frame: Month 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Lallemant principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Anosmia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain regional homogeneity between COVID-19 patients with and without anosmia (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.