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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04407494

Acronym

COVID-OLFA

Enrollment

809

Registered

2020-05-29

Start date

2020-03-01

Completion date

2020-04-30

Last updated

2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

SARS-CoV-2, COVID-19, Diagnostic value, Sensitivity, Specificity, Prevalence, Positive predictive value, Negative predictive value, Epidemiology, Diagnostic test, Anosmia, Ageusia, Olfactory disorders, Gustatory disorders, Smell disorders, Taste disorders

Brief 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.

Interventions

BIOLOGICALReporting 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic values of anosmia and ageusia for COVID-19	at inclusion	Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire

Secondary

Measure	Time frame	Description
Diagnostic values of CODA	at inclusion	Diagnostic values of CODA (Clinical Olfactory dysfunction Assessment) score for COVID-19 : Simple, fast, semi-objective olfactory test developed for epidemic context

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026