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

NCT ID: NCT04407494

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

809 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19

Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.

Reporting of anosmia, ageusia and other clinical symptoms

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fréderic VENAIL, PU-PH

Role: STUDY_DIRECTOR

UH Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0176

Identifier Type: -

Identifier Source: org_study_id

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