Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Biopsy and Cytobrush
Procedure/SurgeryCollection of olfactory cleft biopsies and cytobrushes
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: Olfactory DysfunctionOther 1 intervention
Trial outcomes
Primary outcomes
1
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 month2
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 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
University Hospital, Geneva
Collaborator
Max Planck Research Unit for Neurogenetics
Collaborator
University Hospital Carl Gustav Carus
Collaborator
University of Zurich
Collaborator
Source ClinicalTrials.gov