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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04445597
Other study ID # S64042
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2020
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Laura Van Gerven
Phone +3216336342
Email laura.vangerven@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We aim to understand the mechanism of olfactory dysfunction in COVID-19.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sampling of tissue
In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (5)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven AZ Sint-Jan Brugge-Oostende AV, Hospital Clinic of Barcelona, Max Planck Research Unit for Neurogenetics, Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Immediately after death
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