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

COVID-19 Clinical Trial

— Anosmie-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354857
• Other study ID #: IRB: 20.04.09
• Status: Completed
• Start date: March 27, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: November 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Olfaction Disorders

Intervention

Other:
• olfactory and gustatory tests
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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection status	Positive/negative according to RT-PCR assay	Day 0
Primary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Day 0
Secondary	Ability to detect odor	Ability to smell 1.5ml air freshner on a 0-100 VAS scale	Day 0
Secondary	Ability to detect odor	Ability to smell 1.5ml air freshner on a 0-100 VAS scale	Six months
Secondary	Ability to detect salty taste	Ability to taste a pinch of table salt on a 0-100 VAS scale	Day 0
Secondary	Ability to detect salty taste	Ability to taste a pinch of table salt on a 0-100 VAS scale	Six months
Secondary	Ability to detect sweet taste	Ability to taste a pinch of sugar on a 0-100 VAS scale	Day 0
Secondary	Ability to detect sweet taste	Ability to taste a pinch of sugar on a 0-100 VAS scale	Six months
Secondary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Day 7
Secondary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Day 14
Secondary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Day 30
Secondary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Day 60
Secondary	Severity of infection according to hospitalization rate	% patients hospitalized	End of study (six months)
Secondary	Olfactory and gustatory loss	Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)	Six months