Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection (Anosmie-COVID)

Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

454

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nîmes, France
        • CHU de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,

Description

Inclusion Criteria:

  • Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste
  • Subjects in prolonged contact with COVID-19 infected patients.

Exclusion Criteria:

  • Patients directly admitted to the intensive care unit were excluded
  • Patients opposing use of their health data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RT-PCR SARS-CoV-2 positive

Participants rate quality of sense of smell and taste.

Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor.

Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste

RT-PCR SARS-CoV-2 negative

Participants rate quality of sense of smell and taste.

Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor.

Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 infection status
Time Frame: Day 0
Positive/negative according to RT-PCR assay
Day 0
Olfactory and gustatory loss
Time Frame: Day 0
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to detect odor
Time Frame: Day 0
Ability to smell 1.5ml air freshner on a 0-100 VAS scale
Day 0
Ability to detect odor
Time Frame: Six months
Ability to smell 1.5ml air freshner on a 0-100 VAS scale
Six months
Ability to detect salty taste
Time Frame: Day 0
Ability to taste a pinch of table salt on a 0-100 VAS scale
Day 0
Ability to detect salty taste
Time Frame: Six months
Ability to taste a pinch of table salt on a 0-100 VAS scale
Six months
Ability to detect sweet taste
Time Frame: Day 0
Ability to taste a pinch of sugar on a 0-100 VAS scale
Day 0
Ability to detect sweet taste
Time Frame: Six months
Ability to taste a pinch of sugar on a 0-100 VAS scale
Six months
Olfactory and gustatory loss
Time Frame: Day 7
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Day 7
Olfactory and gustatory loss
Time Frame: Day 14
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Day 14
Olfactory and gustatory loss
Time Frame: Day 30
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Day 30
Olfactory and gustatory loss
Time Frame: Day 60
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Day 60
Severity of infection according to hospitalization rate
Time Frame: End of study (six months)
% patients hospitalized
End of study (six months)
Olfactory and gustatory loss
Time Frame: Six months
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin Lallemant, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2020

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on COVID-19

Clinical Trials on olfactory and gustatory tests

3
Subscribe