COVID-19COVID-OLFANCT04407494
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)
An observational study of COVID-19, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Reporting of anosmia, ageusia and other clinical symptoms
- How many people
- 809 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.
Who may be able to join
- 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)
Who cannot join
- known history of smell and taste disorders
- testing inability (cognitive impairment, non native French speakers, test malingering)
- testing contraindication (children, pregnancy, breastfeeding, specific allergies).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for 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.
- Conditions
- COVID-19
- Being tested
- Reporting of anosmia, ageusia and other clinical symptoms
- 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
- Medical subject headings
- COVID-19, Hypersensitivity, Anosmia, Ageusia, Olfaction Disorders, Taste Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reporting of anosmia, ageusia and other clinical symptomsBiological
Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France. Receives: Biological: Reporting of anosmia, ageusia and other clinical symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic values of anosmia and ageusia for COVID-19
Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire
Measured: at inclusion
Secondary outcomes (1)
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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Mar 2020
- Primary completion1 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 809 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fréderic VENAIL, PU-PH, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407494
- Sponsor's protocol ID
- RECHMPL20_0176
- Acronym
- COVID-OLFA
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders in a Population Tested for COVID-19
- ClinicalTrials.gov ID
- NCT04407494
- Acronym / sponsor ID
- COVID-OLFA / RECHMPL20_0176
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Diagnostic value, Sensitivity, Specificity, Prevalence, Positive predictive value, Negative predictive value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 809 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Biological: Reporting of anosmia, ageusia and other clinical symptomsHealthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers and adult outpatients attending the COVID-19 screening center of the University Hospital of Montpellier, France.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- known history of smell and taste disorders
- testing inability (cognitive impairment, non native French speakers, test malingering)
- testing contraindication (children, pregnancy, breastfeeding, specific allergies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reporting of anosmia, ageusia and other clinical symptomsReporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA | Biological | COVID-19 |
Primary outcome
Diagnostic values of anosmia and ageusia for COVID-19
Time frame: at inclusion
Diagnostic values of anosmia and ageusia for COVID-19 with questionnaire
1 secondary outcome
Diagnostic values of CODA
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fréderic VENAIL, PU-PH study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic values of anosmia and ageusia for COVID-19 (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.