Actively Recruiting
Dysfunction of Olfaction After SARS-CoV-2 Infection: Morphological and Histomolecular Investigation of Olfactory Cleft Biopsies and Cytobrushes
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-06
240
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Geneva
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the persistent loss or alteration of smell (olfactory dysfunction) in patients who have had COVID-19. The study focuses on understanding the underlying biological mechanisms by examining tissues from the olfactory cleft, the area inside the nose responsible for smell. This exploratory clinical study includes patients with and without olfactory dysfunction and uses advanced techniques to analyze the collected samples. Participants will undergo collection of olfactory cleft biopsies and cytobrush samples. These samples are taken either during a scheduled procedure under general anesthesia or during a consultation under local anesthesia. The collected tissues will be studied using single cell RNA sequencing and RNAscope combined with immunohistochemistry to explore molecular and cellular changes. During the study, patients will receive standard care during ENT consultations and diagnostic procedures. The main outcome measures include detailed analysis of the biopsies and cytobrush samples within one month of enrollment. Participants will be monitored by researchers to assess olfactory function and tissue changes. The study is expected to complete by the end of 2026.
CONDITIONS
Brief Title
Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- For olfactory dysfunction group: Presence of clear smell problems such as parosmia or low TDI score (\u226424) and subjective smell impairment rated 5 or higher on a visual scale
- For control group: No olfactory dysfunction with TDI score greater than 30.5
You will not qualify if you...
- Presence of nasal mucosal diseases that may affect smell or bias study results
- Current use of anticoagulation (blood thinning) therapy
- Allergy to local anesthetics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo collection of olfactory cleft biopsies and cytobrushes either during a scheduled structural intervention in general anesthesia or during a consultation in local anesthesia.
1 procedure visit (in-person)
Duration - 1 month
Collected tissue samples will be analyzed using single cell RNA sequencing and RNAscope combined with immunohistochemistry.
No additional visits; analysis performed on collected samples
Trial Site Locations
Total: 7 locations
1
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1000
Actively Recruiting
2
UZ/KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
3
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium, 8000
Actively Recruiting
4
University Hospital Carl Gustav Carus
Dresden, Dresden, Germany, 01307
Actively Recruiting
5
Max Planck Research Unit for Neurogenetics
Frankfurt am Main, Frankfurt, Germany, 60438
Active, Not Recruiting
6
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
7
University of Zurich and University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
L
Laura van Gerven
S
Sabrina Bischoff
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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