ANOSMIC-19: ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT04445597

Collaborator

Max Planck Research Unit for Neurogenetics (Other), AZ Sint-Jan Brugge-Oostende AV (Other), Universitair Ziekenhuis Brussel (Other), Hospital Clinic of Barcelona (Other)

150

Enrollment

Location

Arm

31.8

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Other: Sampling of tissue	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

ANalyzing Olfactory Dysfunction Mechanisms In COVID-19

Actual Study Start Date :

May 7, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: COVID-19 positive or negative patients Hospitalised patients with or without COVID-19 (with or without olfactory dysfunctions)	Other: Sampling of tissue In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed

Arm

Intervention/Treatment

Other: COVID-19 positive or negative patients

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

Other: Sampling of tissue

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

Outcome Measures

Primary Outcome Measures

Prevalence of SARS-CoV-2 in the sampled tissue [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Laura Van Gerven, UZ/KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laura Van Gerven, Professor doctor, Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT04445597

Other Study ID Numbers:

S64042

First Posted:

Jun 24, 2020

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Laura Van Gerven, Professor doctor, Universitaire Ziekenhuizen Leuven

Hyposmia

Anosmia

Olfactory Dysfunction

COVID-19

SARS-CoV-2

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 8, 2022