COVID-19Anosmie-COVIDNCT04354857
Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
An observational study of COVID-19, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- olfactory and gustatory tests
- How many people
- 454 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2020to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: All adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,
Who may be able to join
- Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste
- Subjects in prolonged contact with COVID-19 infected patients.
Who cannot join
- Patients directly admitted to the intensive care unit were excluded
- Patients opposing use of their health data
Trial locations and contacts
1 site in 1 country.
About this study
Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.
- Conditions
- COVID-19
- Being tested
- olfactory and gustatory tests
- Keywords
- anosmia, SARS-Cov-2
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory and gustatory testsOther
Participants rate quality of sense of smell and taste.
Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor.
Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste
| Study group | Role | What they receive |
|---|---|---|
| RT-PCR SARS-CoV-2 positive | Not described Receives: Other: olfactory and gustatory tests | |
| RT-PCR SARS-CoV-2 negative | Not described Receives: Other: olfactory and gustatory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection status
Positive/negative according to RT-PCR assay
Measured: Day 0
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Day 0
Secondary outcomes (12)
Ability to detect odor
Ability to smell 1.5ml air freshner on a 0-100 VAS scale
Measured: Day 0
Ability to detect odor
Ability to smell 1.5ml air freshner on a 0-100 VAS scale
Measured: Six months
Ability to detect salty taste
Ability to taste a pinch of table salt on a 0-100 VAS scale
Measured: Day 0
Ability to detect salty taste
Ability to taste a pinch of table salt on a 0-100 VAS scale
Measured: Six months
Ability to detect sweet taste
Ability to taste a pinch of sugar on a 0-100 VAS scale
Measured: Day 0
Ability to detect sweet taste
Ability to taste a pinch of sugar on a 0-100 VAS scale
Measured: Six months
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Day 7
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Day 14
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Day 30
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Day 60
Severity of infection according to hospitalization rate
% patients hospitalized
Measured: End of study (six months)
Olfactory and gustatory loss
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start27 Mar 2020
- Primary completion31 Jul 2020
- Study completion30 Nov 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 Centre Hospitalier Universitaire de NīmesThe 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
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354857
- Sponsor's protocol ID
- IRB: 20.04.09
- Acronym
- Anosmie-COVID
- Status last verified
- Jun 2021
- First submitted
- 17 Apr 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04354857
- Acronym / sponsor ID
- Anosmie-COVID / IRB: 20.04.09
- Conditions
- COVID-19
- Keywords
- anosmia, SARS-Cov-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 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.
Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT-PCR SARS-CoV-2 positive | – | Other: olfactory and gustatory tests |
| RT-PCR SARS-CoV-2 negative | – | Other: olfactory and gustatory tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,
Key inclusion criteria (2 listed)
- Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste
- Subjects in prolonged contact with COVID-19 infected patients.
Key exclusion criteria (2 listed)
- Patients directly admitted to the intensive care unit were excluded
- Patients opposing use of their health data
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 and gustatory testsParticipants rate quality of sense of smell and taste. Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor. Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste | Other | RT-PCR SARS-CoV-2 negative, RT-PCR SARS-CoV-2 positive |
Primary outcome
SARS-CoV-2 infection status
Time frame: Day 0
Positive/negative according to RT-PCR assay
Olfactory and gustatory loss
Time frame: Day 0
Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)
12 secondary outcomes
Ability to detect odor
Time frame: Day 0
Ability to detect odor
Time frame: Six months
Ability to detect salty taste
Time frame: Day 0
Ability to detect salty taste
Time frame: Six months
Ability to detect sweet taste
Time frame: Day 0
Ability to detect sweet taste
Time frame: Six months
Olfactory and gustatory loss
Time frame: Day 7
Olfactory and gustatory loss
Time frame: Day 14
Olfactory and gustatory loss
Time frame: Day 30
Olfactory and gustatory loss
Time frame: Day 60
Severity of infection according to hospitalization rate
Time frame: End of study (six months)
Olfactory and gustatory loss
Time frame: Six months
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 21 Jun 2021.
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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.
Benjamin Lallemant principal investigator
CHU Nimes
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 Centre Hospitalier Universitaire de Nīmes 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 2 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: finished, as of the sponsor's last update on 21 Jun 2021. 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?
SARS-CoV-2 infection status (time frame: Day 0). The study lists 2 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 21 Jun 2021.