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Recruiting NCT06482138

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

No phase Interventional Covid19 Olfactory Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy and Cytobrush.
Who it may be relevant to
Registry conditions: Covid19, Olfactory Dysfunction. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dysfunction of Olfaction After SARS-CoV-2 Infection: Morphological and Histomolecular Investigation of Olfactory Cleft Biopsies and Cytobrushes

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.

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.

Interventions

  • Procedure Biopsy and Cytobrush
    Collection of olfactory cleft biopsies and cytobrushes

Primary outcome measures

  • Analysis of olfactory cleft biopsies [Time frame: From enrollment of 1 patient until analyzed, 1 month]
  • Analysis of olfactory cytobrushes [Time frame: From enrollment of 1 patient until analyzed, 1 month]

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 \>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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 3 centers
  • Cliniques Universitaires Saint-Luc — Brussels
  • UZ/KU Leuven — Leuven
  • AZ Sint-Jan Brugge — Bruges
Germany · 2 centers
  • University Hospital Carl Gustav Carus — Dresden
  • Max Planck Research Unit for Neurogenetics — Frankfurt am Main
Switzerland · 2 centers
  • Hôpitaux Universitaires de Genève — Geneva
  • University of Zurich and University Hospital Zurich — Zurich

Identifiers

NCT: NCT06482138 · S67380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗