COVID-19 by SARS-CoV-2 InfectionNCT04361565
Frequency and Clinical Evolution of Olfactory and Taste Disorders in COVID-19 Patients
An observational study of COVID-19 by SARS-CoV-2 Infection, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 by SARS-CoV-2 Infection
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2020to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals that responded to a online form
Who may be able to join
- COVID-19 diagnosed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Clinical Evolution of Olfactory and Taste Disorders in Patients Infected by SARS-CoV-2
A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. The aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. The second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.
- Conditions
- COVID-19 by SARS-CoV-2 Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals diagnosed for COVID-19 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anosmia
Prevalence for anosmia in the COVID-19 + patients
Measured: 45 days
Ageusia
Prevalence for ageusia in the COVID-19 + patients
Measured: 45 days
Duration of the loss of anosmia ageusia
Duration measured in days
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Mar 2020
- Primary completion10 Apr 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 by SARS-CoV-2 InfectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361565
- Sponsor's protocol ID
- 20odontocovid01
- Status last verified
- Feb 2025
- First submitted
- 22 Apr 2020
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Evolution of Olfactory and Taste Disorders in Patients Infected by SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04361565
- Acronym / sponsor ID
- 20odontocovid01
- Conditions
- COVID-19 by SARS-CoV-2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Apr 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.
A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. The aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. The second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed for COVID-19 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals that responded to a online form
Key inclusion criteria (1 listed)
- COVID-19 diagnosed
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anosmia
Time frame: 45 days
Prevalence for anosmia in the COVID-19 + patients
Ageusia
Time frame: 45 days
Prevalence for ageusia in the COVID-19 + patients
Duration of the loss of anosmia ageusia
Time frame: 45 days
Duration measured in days
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 18 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 by SARS-CoV-2 Infection, 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 0 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 18 Feb 2025. 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?
Anosmia (time frame: 45 days). The study lists 3 primary outcomes in all. 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 18 Feb 2025.