Olfaction DisordersNCT04526054
Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
A study testing ENT exam, Olfactometry and Brain MRI in people with Olfaction Disorders and COVID-19, run by Hopital Foch at 2 sites in France.
Trial summary
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfaction Disorders, COVID-19
- What is being tested?
- ENT exam, Olfactometry and Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Sep 2020to 3 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patient aged 18 or over
- Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
- Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
- Patient who signed a consent form
- Patient being affiliated to a Health Insurance plan
Who cannot join
- History of chronic rhino-sinusitis with or without polyp (s)
- History of major craniofacial trauma that led to loss of smell
- History of chronic sense of smell
- Diagnosis of Parkinson's disease or Alzheimer's disease
- Refusal to perform the 3 MRIs
- Refusal to participate in the study
Show all 10Show fewer
- Pregnant, parturient or lactating woman
- Patient with contraindications to performing MRI
- Patient not speaking or understanding French
- Patient deprived of liberty or under guardianship
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Raymond Poincare
Garches, 92380
Hopital Foch
Suresnes, Île-de-France Region, 92150
About this study
Official title: Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.
Read the detailed description
Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.
Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.
- Conditions
- Olfaction Disorders, COVID-19
- Being tested
- ENT exam, Olfactometry, Brain MRI
- Keywords
- anosmia, smell disorder, COVID-19, MRI
- Medical subject headings
- Olfaction Disorders, COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENT examDiagnostic test
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
OlfactometryDiagnostic test
Olfactometry test using odorous pens (Sniffin's stick test).
Brain MRIDiagnostic test
Brain MRI focused on the olfactory bulbs (3 teslas).
| Study group | Role | What they receive |
|---|---|---|
| anosmic or normosmic COVID-19 patients | Other | Patients will undergo ENT exams, olfactometry and MRI. Receives: Diagnostic Test: ENT exam; Diagnostic Test: Olfactometry; Diagnostic Test: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
Measured: initial examination
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Measured: initial examination
Secondary outcomes (2)
Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
Measured: initial examination, 6 week to 2 months, 6 to 9 months
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Measured: initial examination, 6 week to 2 months, 6 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start3 Sep 2020
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Raymond Poincaré
- Responsible party
- Sponsor
- Investigators
- Stephane Hans, Pr, Study director, Hopital Foch, SuresnesRobert-Yves Carlier, Pr, Principal investigator, Hopital Raymond Poincare, GarchesJerome Lechien, Dr, Principal investigator, Hopital Foch, Suresnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526054
- Sponsor's protocol ID
- 2020_0057
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
PubMed 32253535
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04526054
- Acronym / sponsor ID
- 2020_0057
- Conditions
- Olfaction Disorders, COVID-19
- Keywords
- anosmia, smell disorder, COVID-19, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Hôpital Raymond Poincaré
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 25 Aug 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.
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.
Detailed description
Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.
Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anosmic or normosmic COVID-19 patients | Other | Diagnostic Test: ENT exam, Diagnostic Test: Olfactometry, Diagnostic Test: Brain MRIPatients will undergo ENT exams, olfactometry and MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 or over
- Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
- Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
- Patient who signed a consent form
- Patient being affiliated to a Health Insurance plan
Key exclusion criteria (10 listed)
- History of chronic rhino-sinusitis with or without polyp (s)
- History of major craniofacial trauma that led to loss of smell
- History of chronic sense of smell
- Diagnosis of Parkinson's disease or Alzheimer's disease
- Refusal to perform the 3 MRIs
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 |
|---|---|---|
| ENT examENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy. | Diagnostic test | anosmic or normosmic COVID-19 patients |
| OlfactometryOlfactometry test using odorous pens (Sniffin's stick test). | Diagnostic test | anosmic or normosmic COVID-19 patients |
| Brain MRIBrain MRI focused on the olfactory bulbs (3 teslas). | Diagnostic test | anosmic or normosmic COVID-19 patients |
Primary outcome
To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Time frame: initial examination
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Time frame: initial examination
Sniffin' test score (T threshold score, D discrimination score, I identification score).
2 secondary outcomes
Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
Time frame: initial examination, 6 week to 2 months, 6 to 9 months
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Time frame: initial examination, 6 week to 2 months, 6 to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 32253535Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
- Individual participant dataSharing planned: No
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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.
Stephane Hans, Pr study director
Hopital Foch, Suresnes
Robert-Yves Carlier, Pr principal investigator
Hopital Raymond Poincare, Garches
Jerome Lechien, Dr principal investigator
Hopital Foch, Suresnes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENT exam, Olfactometry and Brain MRI in people with Olfaction Disorders and COVID-19, run by Hopital Foch at 2 sites 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients. (time frame: initial examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526054, which also lists 1 linked publication.
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 3 Aug 2022.