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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Olfactory Dysfunction; Covid19

Treatments: Procedure: Biopsy and Cytobrush

Study type: Interventional

Funder types: Other

Identifiers

NCT06482138

S67380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control

Other group

Description:

Biopsy and cytobrush during a scheduled structural intervention in general anesthesia

Treatment:

Procedure: Biopsy and Cytobrush

Olfactory Dysfunction

Other group

Description:

Biopsy and cytobrush during consultation in local anesthesia

Treatment:

Procedure: Biopsy and Cytobrush