Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation

Universitaire Ziekenhuizen KU Leuven240 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

240

Conditions

Covid19 Olfactory Dysfunction

Interventions

Biopsy and CytobrushPROCEDURE

Collection of olfactory cleft biopsies and cytobrushes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 \>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

Locations (7)

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

RECRUITING

UZ/KU Leuven

Leuven, Vlaams-Brabant, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

Outcomes

Primary Outcomes

Analysis of olfactory cleft biopsies

Morphological and histomolecular differences between OD and control patients * Evaluating tissue pathology: * Metaplasia * hypertrophy * aberrant scar formation * apoptosis * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\] * Presence of SARS-CoV-2 RNA * Percentage of OSNs versus sustentacular cells; maturation of OSNs

Time frame: From enrollment of 1 patient until analyzed, 1 month

Analysis of olfactory cytobrushes

Morphological and histomolecular differences between OD and control patients * Evaluating tissue pathology: * Metaplasia * hypertrophy * aberrant scar formation * apoptosis * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\] * Presence of SARS-CoV-2 RNA * In the olfactory epithelium: percentage of OSNs versus sustentacular cells; maturation of OSNs

Time frame: From enrollment of 1 patient until analyzed, 1 month

Central Contacts

Laura van Gerven

CONTACT

+3216336342 laura.vangerven@uzleuven.be

Sabrina Bischoff

CONTACT

+41763655671 sabrina.bischoff@uzleuven.be

Data from ClinicalTrials.gov

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