Olfaction DisordersOLFASCANNCT04696601
Rapid Screening for Olfactory Disorders in Covid-19 Infection
A study testing Olfactory test in people with Olfaction Disorders and COVID-19 Testing, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olfaction Disorders, COVID-19 Testing
- What is being tested?
- Olfactory test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- 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
Who may be able to join
- Subject presenting himself at the covid-19 screening centre set up by the city of Nice
Who cannot join
- Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
- Subject receiving cancer chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.
The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.
- Conditions
- Olfaction Disorders, COVID-19 Testing
- Being tested
- Olfactory test
- Keywords
- Olfaction Disorders, Hyposmia, Dysosmia, Anosmia, Covid-19
- Medical subject headings
- Olfaction Disorders, Anosmia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory testDiagnostic test
The olfactory test (Olfascan) is in the form of a paper stick, previously impregnated with an odorant (non-liquid). It is placed a few centimetres from the participant's nose at the time of the test. It is a single-use test, without contact with the participant.
| Study group | Role | What they receive |
|---|---|---|
| Olfactory test | Experimental | The result of the olfactory test will be compared to the result of the RT-PCR test. Receives: Diagnostic Test: Olfactory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory test
Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Because of logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud DAVID, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696601
- Sponsor's protocol ID
- 20-PP-27
- Acronym
- OLFASCAN
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Screening for Olfactory Disorders in Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04696601
- Acronym / sponsor ID
- OLFASCAN / 20-PP-27
- Conditions
- Olfaction Disorders, COVID-19 Testing
- Keywords
- Olfaction Disorders, Hyposmia, Dysosmia, Anosmia, Covid-19
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 6 Jan 2021 (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.
Loss of smell is very frequently found in Europe during Covid-19 attack. This symptom was not initially expected as part of the classic symptomatology. This loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. As a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of Covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards RT-PCR-type screening. In the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions.
The objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. The diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olfactory test | Experimental | Diagnostic Test: Olfactory testThe result of the olfactory test will be compared to the result of the RT-PCR test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject presenting himself at the covid-19 screening centre set up by the city of Nice
Key exclusion criteria (2 listed)
- Presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test.
- Subject receiving cancer chemotherapy
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 |
|---|---|---|
| Olfactory testThe olfactory test (Olfascan) is in the form of a paper stick, previously impregnated with an odorant (non-liquid). It is placed a few centimetres from the participant's nose at the time of the test. It is a single-use test, without contact with the participant. | Diagnostic test | Olfactory test |
Primary outcome
Olfactory test
Time frame: Day 0
Sensitivity of the olfactory test (Olfascan) for measuring anosmia, compared to the reference diagnostic test (RT-PCR analysis).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Renaud DAVID, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory test in people with Olfaction Disorders and COVID-19 Testing, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Feb 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Olfactory test (time frame: Day 0). 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 7 Feb 2024.