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

NCT04407494 | Completed

• 1 other identifier: RECHMPL20_0176
• Study Type: observational
• Target: 809
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic values of anosmia and ageusia for COVID-19

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

  at inclusion

Secondary Outcomes (1)

• Diagnostic values of CODA

  at inclusion

Study Arms (1)

COVID-19

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

Biological: Reporting of anosmia, ageusia and other clinical symptoms

Interventions

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

COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• known history of smell and taste disorders
• testing inability (cognitive impairment, non native French speakers, test malingering)
• testing contraindication (children, pregnancy, breastfeeding, specific allergies).

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

COVID-19; Hypersensitivity; Anosmia; Ageusia; Olfaction Disorders; Taste Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Immune System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fréderic VENAIL, PU-PH

  UH Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: March 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 30, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

FR (1)