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OpenTrials
Completed

NCT Number: NCT04407494

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

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.

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Key information

Conditions

COVID-19 Ageusia Anosmia Coronaviridae Infections Coronavirus Infections Hypersensitivity Immune System Diseases Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Taste Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Reporting of anosmia, ageusia and other clinical symptoms

Biological

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

Primary outcomes

  1. Diagnostic values of anosmia and ageusia for COVID-19

    Time frame: at inclusion

    Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire

Secondary outcomes

  1. Diagnostic values of CODA

    Time frame: at inclusion

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: COVID-OLFA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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