Investigating olfactory dysfunction after COVID-19 infection
Dysfunction of Olfaction After SARS-CoV-2 Infection: Morphological and Histomolecular Investigation of Olfactory Cleft Biopsies and Cytobrushes
NA · Universitaire Ziekenhuizen KU Leuven · NCT06482138
This study is trying to understand why some people still have trouble smelling after recovering from COVID-19 by looking at samples from their noses.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 7 sites (Brussels, Brussels Capital and 6 other locations) |
| Trial ID | NCT06482138 on ClinicalTrials.gov |
What this trial studies
This study explores the mechanisms behind persistent olfactory dysfunction in patients who have recovered from COVID-19. It involves collecting biopsies and cytobrush samples from the olfactory cleft of patients with and without olfactory dysfunction. The samples will be analyzed using advanced techniques such as single cell RNA sequencing and immunohistochemistry to understand the underlying biological changes. Patients will be evaluated by ENT specialists as part of their standard care.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced olfactory dysfunction following COVID-19, as well as those who have not experienced any olfactory issues.
Not a fit: Patients with other nasal mucosal pathologies or those on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for patients suffering from olfactory dysfunction after COVID-19.
How similar studies have performed: While there have been studies on olfactory dysfunction, this specific investigation into post-COVID-19 olfactory dysfunction using advanced molecular techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels, Brussels Capital and 6 other locations
- Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital, Belgium (RECRUITING)
- UZ/KU Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
- AZ Sint-Jan Brugge — Bruges, West-Vlaanderen, Belgium (RECRUITING)
- University Hospital Carl Gustav Carus — Dresden, Dresden, Germany (RECRUITING)
- Max Planck Research Unit for Neurogenetics — Frankfurt am Main, Frankfurt, Germany (ACTIVE_NOT_RECRUITING)
- Hôpitaux Universitaires de Genève — Geneva, Canton of Geneva, Switzerland (RECRUITING)
- University of Zurich and University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Laura van Gerven — UZ/KU Leuven
- Study coordinator: Laura van Gerven
- Email: laura.vangerven@uzleuven.be
- Phone: +3216336342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Covid19, Olfactory Dysfunction, COVID-19, SARS-CoV-2, Anosmia, Hyposmia