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

Completed

• Conditions: COVID-19
• Interventions: Other: olfactory and gustatory tests

• Registration Number: NCT04354857
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-27
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Primary Completion: 2020-07-31
• Study Completion: 2020-11-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RT-PCR SARS-CoV-2 positive	olfactory and gustatory tests	-
RT-PCR SARS-CoV-2 negative	olfactory and gustatory tests	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France