Rapid Screening for Olfactory Disorders in Covid-19 Infection (OLFASCAN)
Primary Purpose
Olfaction Disorders, COVID-19 Testing
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Olfactory test
Sponsored by
About this trial
This is an interventional screening trial for Olfaction Disorders focused on measuring Olfaction Disorders, Hyposmia, Dysosmia, Anosmia, Covid-19
Eligibility Criteria
Inclusion Criteria:
- Subject presenting himself at the covid-19 screening centre set up by the city of Nice
Exclusion Criteria:
- Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
- Subject receiving cancer chemotherapy
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olfactory test
Arm Description
The result of the olfactory test will be compared to the result of the RT-PCR test.
Outcomes
Primary Outcome Measures
Olfactory test
Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).
Secondary Outcome Measures
Full Information
NCT ID
NCT04696601
First Posted
December 23, 2020
Last Updated
January 5, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04696601
Brief Title
Rapid Screening for Olfactory Disorders in Covid-19 Infection
Acronym
OLFASCAN
Official Title
Rapid Screening for Olfactory Disorders in Covid-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2021 (Anticipated)
Primary Completion Date
February 10, 2021 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.
The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfaction Disorders, COVID-19 Testing
Keywords
Olfaction Disorders, Hyposmia, Dysosmia, Anosmia, Covid-19
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Olfactory test
Arm Type
Experimental
Arm Description
The result of the olfactory test will be compared to the result of the RT-PCR test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Olfactory test
Intervention Description
The olfactory test (Olfascan) is in the form of a paper stick, previously impregnated with an odorant (non-liquid). It is placed a few centimetres from the participant's nose at the time of the test. It is a single-use test, without contact with the participant.
Primary Outcome Measure Information:
Title
Olfactory test
Description
Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject presenting himself at the covid-19 screening centre set up by the city of Nice
Exclusion Criteria:
Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
Subject receiving cancer chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud DAVID, Dr
Phone
4 92 03 43 99
Ext
+33
Email
david.r@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud DAVID, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud DAVID, Dr
Phone
4 92 03 43 99
Ext
+33
Email
david.r@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rapid Screening for Olfactory Disorders in Covid-19 Infection
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