- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354857
Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection (Anosmie-COVID)
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes, France
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Benjamin Lallemant, CHU Nîmes
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
- Olfaction Disorders
- COVID-19
- Anosmia
Other Study ID Numbers
- IRB: 20.04.09
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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