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NCT04407494 Clinical Trial

Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)

COVID-19 Clinical Trial

— COVID-OLFA  

Official title:
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04407494
Other study ID # RECHMPL20_0176
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date April 30, 2020

Study information
Verified date May 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Participants are healthcare workers and adult outpatients referred in a COVID-19 screening center. Patients-reported symptoms are collected, then participants underwent a simple olfactory test (CODA for Clinical Olfactory Dysfunction Assessment), prior to swabbing for SARS-CoV-2 diagnosis (RT-PCR). We aimed to evaluate the prevalence of smell and taste disorders, and to calculate the diagnostic value of patient-reported and clinically verified smell disorders in persons with suspected COVID-19.

Recruitment information / eligibility
Status Completed
Enrollment 809
Est. completion date April 30, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Symptoms compatible with COVID-19

- Close exposure to a confirmed COVID-19 index case

- Ambulatory (asymptomatic, or if symptomatic, did not require hospitalisation, thus with initial mild disease)

Exclusion criteria:

- known history of smell and taste disorders

- testing inability (cognitive impairment, non native French speakers, test malingering)

- testing contraindication (children, pregnancy, breastfeeding, specific allergies).

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Reporting of anosmia, ageusia and other clinical symptoms
Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic values of anosmia and ageusia for COVID-19 Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire at inclusion
Secondary Diagnostic values of CODA Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context at inclusion
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