ANalyzing Olfactory Dysfunction Mechanisms In COVID-19 (ANOSMIC-19)
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura van Gerven
- Phone Number: +3216336342
- Email: laura.vangerven@uzleuven.be
Study Contact Backup
- Name: Marnick Clijsters
- Phone Number: +3216336342
- Email: marnick.clijsters@kuleuven.be
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- UZ Leuven
-
Contact:
- Laura Van Gerven, Doctor
- Phone Number: +3216336342
- Email: laura.vangerven@uzleuven.be
-
Contact:
- Marnick Clijsters
- Phone Number: +3216336342
- Email: marnick.clijsters@uzleuven.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: COVID-19 positive or negative patients
Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)
|
In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Immediately after death
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura van Gerven, UZ/KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S64042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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