RecruitingNAINTERVENTIONAL

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

This research study, called "Dysfunction of Olfaction After COVID-19 Infection," aims to discover why some individuals continue to experience a changed or lost sense of smell (olfactory dysfunction) after recovering from COVID-19. Researchers will collect tiny tissue samples from the inside of the nose (specifically, the olfactory cleft) from people who have had COVID-19 – both those who still have smell problems and those who don't. They will also collect samples from people who haven't had COVID-19. By carefully studying these samples, they hope to understand the underlying causes of persistent smell loss, which could eventually lead to better treatments. This is an exploratory study, meaning it's looking to gather new information about this condition.

At a glance

Status

Recruiting

Phase

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrolment target

240

Start

24 Jan 2024

Estimated completion

31 Dec 2026

Covid19 Olfactory Dysfunction

What is this study about?

This study is designed to understand a puzzling problem that many people face after having COVID-19: a long-lasting change or loss of their sense of smell. This condition, often called 'olfactory dysfunction,' can be very upsetting and affect daily life. The researchers want to look closely at the tiny structures inside the nose that are responsible for smell. By doing so, they hope to unlock the mystery of why some people recover their sense of smell quickly, while for others, the problem lingers.

To do this, the study will involve collecting very small tissue samples from the upper part of the nose, called the olfactory cleft. They will use two methods: a 'biopsy,' which is a tiny piece of tissue, and a 'cytobrush,' which is like a small brush that collects cells. These samples will be taken from people who experienced COVID-19 and still have smell issues, as well as from people who had COVID-19 but fully recovered their smell. They will also collect samples from healthy people who haven't had COVID-19 to use as a comparison.

Once collected, these samples will be studied in great detail using advanced laboratory techniques. The goal is to find out what exactly is happening at a cellular and molecular level that might be causing the persistent smell problems. Understanding these mechanisms is the first crucial step towards developing effective treatments to help people regain their sense of smell and improve their quality of life.

Key takeaways

Aims to understand long-lasting smell problems after COVID-19.
Researchers will collect small samples from inside the nose.
Involves regular medical check-ups with an ENT specialist.
No new medications are given as part of the study.
Participation helps future patients with smell loss.

Who may be eligible?

To join this study, participants need to be between 18 and 70 years old. Both men and women are welcome to take part.

There are two main groups for this study. One group will be for people who still have noticeable problems with their sense of smell after COVID-19. This includes having a distorted smell (parosmia), struggling to identify different scents, or rating their smell impairment as moderate to severe.

The other group will be for people who do not have any smell problems. These participants would have a normal ability to distinguish smells. You wouldn't be able to join if you have other ongoing nose problems that could affect your sense of smell, if you’re taking blood-thinning medication, or if you're allergic to the numbing medicine used in clinics.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you currently have ongoing, noticeable smell problems after COVID-19, or do you have a normal sense of smell?
Do you have any other ongoing nose conditions that might affect your sense of smell?
Are you currently taking blood-thinning medication?
Are you allergic to local anaesthetics (numbing medicine)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a check-up with an ear, nose, and throat (ENT) specialist. This visit is part of the standard care you would receive for your condition, not just for the study.

During this visit, the research team will collect tiny samples from the inside of your nose. This involves a small biopsy, where a tiny piece of tissue is taken, and also using a small brush, called a cytobrush, to collect cells. This procedure will be done carefully with local anaesthetic to minimise discomfort.

The study does not involve taking any new medications, and there are no extra follow-up visits specifically for the research beyond your regular medical appointments. The total duration of your direct participation in the study, involving the collection of samples, would be during that single clinic visit.

Potential risks and benefits

Participating in this study might not offer direct health benefits to you, but the information gained could greatly help future patients suffering from smell loss after COVID-19 by leading to better understanding and potential treatments. As with any medical procedure, there are some minor risks, such as temporary discomfort or a small amount of bleeding from the sample collection, though local anaesthetic will be used. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (7)

Cliniques Universitaires Saint-Luc
Verified postcode
Brussels, Belgium· Recruiting
UZ/KU Leuven
Verified postcode
Leuven, Belgium· Recruiting
AZ Sint-Jan Brugge
Verified postcode
Bruges, Belgium· Recruiting
University Hospital Carl Gustav Carus
Verified postcode
Dresden, Germany· Recruiting
Max Planck Research Unit for Neurogenetics
Verified postcode
Frankfurt am Main, Germany· Active not recruiting
Hôpitaux Universitaires de Genève
Verified postcode
Geneva, Switzerland· Recruiting
University of Zurich and University Hospital Zurich
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is 'olfactory dysfunction'?

It's a medical term for problems with your sense of smell, like losing it, having it change, or smelling things that aren't there.

Is this study only for people who had COVID-19?

Yes, it mostly focuses on people who had COVID-19, both those with and without smell problems, but it also includes some healthy people for comparison.

What is a 'biopsy' from the nose?

It's when a very small piece of tissue is carefully removed from the inside of your nose, usually while you're numbed with local anaesthetic.

Will I have to take any new medicine for this study?

No, this study does not involve taking any new medications. It's focused on collecting and studying samples.

How long will my participation take?

Your direct participation in the study, involving sample collection, will happen during a single clinic visit that you would already be attending for your medical care.

How to find out more

Laura van Gerven

laura.vangerven@uzleuven.be +3216336342 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.