SARS-CoV-2ANOSMIC-19NCT04445597
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
A study testing Sampling of tissue in people with SARS-CoV-2, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
We aim to understand the mechanism of olfactory dysfunction in COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Sampling of tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Laura Van Gerven, Doctor, +3216336342, laura.vangerven@uzleuven.be
Marnick Clijsters, +3216336342, marnick.clijsters@uzleuven.be
About this study
We aim to understand the mechanism of olfactory dysfunction in COVID-19.
Read the detailed description
In December 2019, a new coronavirus causing severe acute respiratory syndrome was described in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health Organization.
By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.
In the present study, the investigators wish to begin to understand the pathogenesis of olfactory dysfunction in COVID-19.
- Conditions
- SARS-CoV-2
- Being tested
- Sampling of tissue
- Keywords
- Hyposmia, Anosmia, Olfactory Dysfunction, COVID-19, SARS-CoV-2
- Medical subject headings
- Anosmia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of tissueOther
In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive or negative patients | Other | Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions) Receives: Other: Sampling of tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SARS-CoV-2 in the sampled tissue
In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics
Measured: Immediately after death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start7 May 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Research Unit for Neurogenetics, AZ Sint-Lucas Brugge, Universitair Ziekenhuis Brussel, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Laura Van Gerven, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445597
- Sponsor's protocol ID
- S64042
- Acronym
- ANOSMIC-19
- Status last verified
- May 2023
- First submitted
- 22 Jun 2020
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
- ClinicalTrials.gov ID
- NCT04445597
- Acronym / sponsor ID
- ANOSMIC-19 / S64042
- Conditions
- SARS-CoV-2
- Keywords
- Hyposmia, Anosmia, Olfactory Dysfunction, COVID-19, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Max Planck Research Unit for Neurogenetics, AZ Sint-Lucas Brugge, Universitair Ziekenhuis Brussel, Hospital Clinic of Barcelona
- Study start
- 7 May 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to understand the mechanism of olfactory dysfunction in COVID-19.
Detailed description
In December 2019, a new coronavirus causing severe acute respiratory syndrome was described in Wuhan, China. This virus, later named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), spread worldwide and has been designated a pandemic by the World Health Organization.
By the beginning of March 2020, several Ear, Nose, Throat societies raised awareness of a frequent association between coronavirus disease 2019 (COVID-19) and smell disorders.
In the present study, the investigators wish to begin to understand the pathogenesis of olfactory dysfunction in COVID-19.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive or negative patients | Other | Other: Sampling of tissueHospitalised patients with or without COVID-19 (with or without olfactory dysfunctions) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of tissueIn all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed | Other | COVID-19 positive or negative patients |
Primary outcome
Prevalence of SARS-CoV-2 in the sampled tissue
Time frame: Immediately after death
In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Van Gerven principal investigator
UZ/KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of tissue in people with SARS-CoV-2, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Van Gerven (+3216336342, laura.vangerven@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARS-CoV-2 in the sampled tissue (time frame: Immediately after death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.