Clinical trial NCT06482138: Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
Official title: Dysfunction of Olfaction After SARS-CoV-2 Infection: Morphological and Histomolecular Investigation of Olfactory Cleft Biopsies and Cytobrushes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Covid19
Olfactory Dysfunction
Keywords: Olfactory Dysfunction
COVID-19
SARS-CoV-2
Anosmia
Hyposmia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Max Planck Research Unit for Neurogenetics
name: University Hospital Carl Gustav Carus
name: University of Zurich
First posted: 2024-07-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of the mechanisms of persistent SARS-CoV-2 associated olfactory dysfunction (OD) in patients with well-documented olfactory function. The investigators plan to collect olfactory cleft biopsies and cytobrushes in COVID-19 patients and controls.

Detailed description: An explorative prospective clinical study using human body materials of living post-COVID-19 patients with and without OD, to study the mechanisms of persisting olfactory dysfunction. Patients consult ENT specialist for medical purposes and undergo standard-of-care diagnostics and management. The collected tissues from the olfactory cleft mucosa will be analyzed using single cell RNA sequencing and RNAscope combined with immunohistochemistry.

Eligibility criteria: Inclusion Criteria:

* Olfactory Dysfunction group: Presence of evident OD (Parosmia, Threshold-Discrimination-Identification (TDI)-score ≤24, Subjective abnormal quantitative olfactory function; measured by a visual analogue score (VAS) of smell impairment ≥5/10
* Control group: No OD (TDI-score \&gt;30.5.)

Exclusion Criteria:

* Presence of concomitant nasal mucosal pathology that might affect olfactory function or bias the study investigations
* Use of anticoagulation therapy
* Allergy to local anesthetics

Primary outcomes:
measure: Analysis of olfactory cleft biopsies
timeFrame: From enrollment of 1 patient until analyzed, 1 month
measure: Analysis of olfactory cytobrushes
timeFrame: From enrollment of 1 patient until analyzed, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ/KU Leuven
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Frankfurt am Main
country: Germany
facility: Max Planck Research Unit for Neurogenetics
state: Frankfurt
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Zürich
country: Switzerland
facility: University of Zurich and University Hospital Zurich
Study officials:
affiliation: UZ/KU Leuven
name: Laura van Gerven
role: PRINCIPAL_INVESTIGATOR
References: