Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526054
• Other study ID #: 2020_0057
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 dysfunction.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Pregnant, parturient or lactating woman

• Patient with contraindications to performing MRI

• Patient not speaking or understanding French

• Patient deprived of liberty or under guardianship

Related Conditions & MeSH terms

• COVID-19
• Olfaction Disorders

Intervention

Diagnostic Test:
• ENT exam
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
• Olfactometry
Olfactometry test using odorous pens (Sniffin's stick test).
• Brain MRI
Brain MRI focused on the olfactory bulbs (3 teslas).

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches
France	Hopital Foch	Suresnes	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Foch	Hôpital Raymond Poincaré

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	initial examination
Primary	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).	initial examination
Secondary	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.	initial examination, 6 week to 2 months, 6 to 9 months
Secondary	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).	initial examination, 6 week to 2 months, 6 to 9 months