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

NCT06482138 · tracked via the Priya Life Science Germany tracker

Sponsor

Universitaire Ziekenhuizen KU Leuven

Phase

Not applicable

Started

2024-01-24

Last updated

2026-05-06

Condition(s) studied

Covid19Olfactory Dysfunction

Investigational drug(s) / intervention(s)

Biopsy and Cytobrush

Biopsy and Cytobrush: Collection of olfactory cleft biopsies and cytobrushes

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Analysis of olfactory cleft biopsies — From enrollment of 1 patient until analyzed, 1 month
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
Analysis of olfactory cytobrushes — From enrollment of 1 patient until analyzed, 1 month
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

Trial sites (7)

Facility	City	Region	Status
Cliniques Universitaires Saint-Luc	Brussels	Brussels Capital	Recruiting
UZ/KU Leuven	Leuven	Vlaams-Brabant	Recruiting
AZ Sint-Jan Brugge	Bruges	West-Vlaanderen	Recruiting
University Hospital Carl Gustav Carus	Dresden	Dresden	Recruiting
Max Planck Research Unit for Neurogenetics	Frankfurt am Main	Frankfurt	Active Not Recruiting
Hôpitaux Universitaires de Genève	Geneva	Canton of Geneva	Recruiting
University of Zurich and University Hospital Zurich	Zurich	Canton of Zurich	Recruiting

More Universitaire Ziekenhuizen KU Leuven trials in Germany

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The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06482138 on ClinicalTrials.gov ↗ ← All trials in Germany