NCT04445597

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

3.7 years

First QC Date

June 22, 2020

Last Update Submit

May 26, 2023

Conditions

SARS-CoV-2

Keywords

HyposmiaAnosmiaOlfactory DysfunctionCOVID-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

COVID-19 positive or negative patients

OTHER

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

Other: Sampling of tissue

Interventions

Sampling of tissueOTHER

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

COVID-19 positive or negative patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

AnosmiaCOVID-19

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Laura Van Gerven

    UZ/KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Van Gerven

CONTACT

+3216336342laura.vangerven@uzleuven.be

Marnick Clijsters

CONTACT

+3216336342marnick.clijsters@kuleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor doctor

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

May 7, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)