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

NCT ID: NCT06482138

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Covid19 Olfactory Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Biopsy and cytobrush during a scheduled structural intervention in general anesthesia

Group Type OTHER

Biopsy and Cytobrush

Intervention Type PROCEDURE

Collection of olfactory cleft biopsies and cytobrushes

Olfactory Dysfunction

Biopsy and cytobrush during consultation in local anesthesia

Group Type OTHER

Biopsy and Cytobrush

Intervention Type PROCEDURE

Collection of olfactory cleft biopsies and cytobrushes

Interventions

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Biopsy and Cytobrush

Collection of olfactory cleft biopsies and cytobrushes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role collaborator

Max Planck Research Unit for Neurogenetics

UNKNOWN

Sponsor Role collaborator

University Hospital Carl Gustav Carus

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura van Gerven

Role: PRINCIPAL_INVESTIGATOR

UZ/KU Leuven

Locations

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Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

UZ/KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

AZ Sint-Jan Brugge

Bruges, West-Vlaanderen, Belgium

Site Status RECRUITING

University Hospital Carl Gustav Carus

Dresden, Dresden, Germany

Site Status RECRUITING

Max Planck Research Unit for Neurogenetics

Frankfurt am Main, Frankfurt, Germany

Site Status ACTIVE_NOT_RECRUITING

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

University of Zurich and University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Belgium Germany Switzerland

Central Contacts

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Laura van Gerven

Role: CONTACT

+3216336342

Sabrina Bischoff

Role: CONTACT

+41763655671

Facility Contacts

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Caroline Huart

Role: primary

0477910294

Laura van Gerven

Role: primary

+3216336342

Kato Speleman

Role: primary

0477910294

Thomas Hummel

Role: primary

+493514582264

Basile Landis

Role: primary

+41 223728268

Michael Soyka

Role: primary

+41 432538819

Other Identifiers

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S67380

Identifier Type: -

Identifier Source: org_study_id

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