Covid19, Olfactory Dysfunction
Conditions
Keywords
Olfactory Dysfunction, COVID-19, SARS-CoV-2, Anosmia, Hyposmia
Brief 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.
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
PROCEDUREBiopsy and Cytobrush
Collection of olfactory cleft biopsies and cytobrushes
Sponsors
Universitaire Ziekenhuizen KU Leuven
University Hospital, Geneva
Max Planck Research Unit for Neurogenetics
University Hospital Carl Gustav Carus
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium, Germany, Switzerland
Contacts
CONTACTLaura van Gerven
CONTACTSabrina Bischoff
PRINCIPAL_INVESTIGATORLaura van Gerven
UZ/KU Leuven
Outcome results
None listed