Clinical trial NCT04526054: Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Official title: Longitudinal and Comparative Study of Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfaction Disorders
COVID-19
Keywords: anosmia
smell disorder
COVID-19
MRI
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Hôpital Raymond Poincaré
First posted: 2020-08-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: initial examination
measure: To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
timeFrame: initial examination
Secondary outcomes:
measure: 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.
timeFrame: initial examination, 6 week to 2 months, 6 to 9 months
measure: To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
timeFrame: initial examination, 6 week to 2 months, 6 to 9 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile-de-France
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: Hopital Foch, Suresnes
name: Stephane Hans, Pr
role: STUDY_DIRECTOR
affiliation: Hopital Raymond Poincare, Garches
name: Robert-Yves Carlier, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch, Suresnes
name: Jerome Lechien, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.