Rapid Screening for Olfactory Disorders in Covid-19 Infection

NCT04696601 | Withdrawn

• 1 other identifier: 20-PP-27
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfaction Disorders; COVID-19 Testing

Keywords

Olfaction Disorders; Hyposmia; Dysosmia; Anosmia; Covid-19

Outcome Measures

Primary Outcomes (1)

• Olfactory test

  Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).

  Day 0

Study Arms (1)

Olfactory test

EXPERIMENTAL

The result of the olfactory test will be compared to the result of the RT-PCR test.

Diagnostic Test: Olfactory test

Interventions

Olfactory test DIAGNOSTIC_TEST

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.

Olfactory test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject presenting himself at the covid-19 screening centre set up by the city of Nice

You may not qualify if:

• Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
• Subject receiving cancer chemotherapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Olfaction Disorders; Anosmia; COVID-19

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Renaud DAVID, Dr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: January 8, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)