search
Back to results

ANalyzing Olfactory Dysfunction Mechanisms In COVID-19 (ANOSMIC-19)

Primary Purpose

SARS-CoV-2

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sampling of tissue
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for SARS-CoV-2 focused on measuring Hyposmia, Anosmia, Olfactory Dysfunction, COVID-19, SARS-CoV-2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively

Exclusion Criteria:

  • none

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 positive or negative patients

Arm Description

Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 22, 2020
Last Updated
May 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Max Planck Research Unit for Neurogenetics, AZ Sint-Jan Brugge-Oostende AV, Universitair Ziekenhuis Brussel, Hospital Clinic of Barcelona
search

1. Study Identification

Unique Protocol Identification Number
NCT04445597
Brief Title
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
Acronym
ANOSMIC-19
Official Title
ANalyzing Olfactory Dysfunction Mechanisms In COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Max Planck Research Unit for Neurogenetics, AZ Sint-Jan Brugge-Oostende AV, Universitair Ziekenhuis Brussel, Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2
Keywords
Hyposmia, Anosmia, Olfactory Dysfunction, COVID-19, SARS-CoV-2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 positive or negative patients
Arm Type
Other
Arm Description
Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)
Intervention Type
Other
Intervention Name(s)
Sampling of tissue
Intervention Description
In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed
Primary Outcome Measure Information:
Title
Prevalence of SARS-CoV-2 in the sampled tissue
Description
In the sampled tissues, the investigators will determine presence of SARS-CoV-2 by means of immunohistochemistry, RNA-scope and spatial transcriptomics
Time Frame
Immediately after death

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Deceased hospitalised patients, tested positive or negative for SARS-CoV-2 for patient or control group respectively Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Van Gerven
Phone
+3216336342
Email
laura.vangerven@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marnick Clijsters
Phone
+3216336342
Email
marnick.clijsters@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Van Gerven
Organizational Affiliation
UZ/KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Van Gerven, Doctor
Phone
+3216336342
Email
laura.vangerven@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Marnick Clijsters
Phone
+3216336342
Email
marnick.clijsters@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

We'll reach out to this number within 24 hrs