COVID-19 Clinical Trial
— COVID-OLFAOfficial title:
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19
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 |
Verified date | May 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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