- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696601
Rapid Screening for Olfactory Disorders in Covid-19 Infection (OLFASCAN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Renaud DAVID, Dr
- Phone Number: +33 4 92 03 43 99
- Email: david.r@chu-nice.fr
Study Locations
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Nice, France, 06003
- CHU de Nice
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Contact:
- Renaud DAVID, Dr
- Phone Number: +33 4 92 03 43 99
- Email: david.r@chu-nice.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olfactory test
The result of the olfactory test will be compared to the result of the RT-PCR test.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Olfactory test
Time Frame: Day 0
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Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).
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Day 0
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Collaborators and Investigators
Investigators
- Principal Investigator: Renaud DAVID, Dr, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurologic Manifestations
- Sensation Disorders
- COVID-19
- Olfaction Disorders
Other Study ID Numbers
- 20-PP-27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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