Covid19COVIDANOSMIANCT04806880
Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
An observational study of Covid19, run by Weprom at 1 site in France.
Trial summary
Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Web-application
- Type of treatment
- Medical device
- How many people
- 1,155 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 1 Aug 2021
- How long will I take part?
- 16 Weeks
- 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 users of the application who have not objected to the use of their data
Who may be able to join
- Post-COVID anosmia lasting more than 1 month
- Consent to the use of data via the application
Who cannot join
- Other causes of anosmia than COVID
- Contraindication to olfactory coaching (allergy to one of the aromatic oils)
- Minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. However, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia In the context of the health crisis linked to the coronavirus, approximately 1 million French people will have persistent anosmia following an infection with COVID-19. A web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching.
covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.
- Conditions
- Covid19
- Being tested
- Web-application
- Keywords
- Web-application, Anosmia, COVID-19, coaching
- 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.
Web-applicationDevice
support for olfactory coaching consisting of the inhalation of fragrant essential oils.
| Study group | Role | What they receive |
|---|---|---|
| users | Users of web-application Receives: Device: Web-application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the rate of patients presenting an improvement in their anosmia
Number of patients with an improvement in anosmia (increase of at least 1 point on the visual analogue scale 0-10) on the number of users
Measured: 16 weeks
Secondary outcomes (3)
Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,
Time between the date of first use of the application and the date of recovery of at least one point of anosmia
Measured: 16 weeks
Assessment of the duration of anosmia
Time between the date of diagnosis or onset of anosmia and the date of final recovery
Measured: 16 weeks
Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils
Evolution of the VAS according to the different oils, proportion of patients with an increase of at least 1 point in anosmia on a visual analog scale (from 0 no smell to 10 normal smell) of each oil
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start25 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- 1,155 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Kelindi, Centre National de la Recherche Scientifique, France, Hospital of Tours
- Responsible party
- Sponsor
- Investigators
- Fabrice DENIS, MD, Study director, Weprom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806880
- Sponsor's protocol ID
- WP-2020-06
- Acronym
- COVIDANOSMIA
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 11 Oct 2021
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
- ClinicalTrials.gov ID
- NCT04806880
- Acronym / sponsor ID
- COVIDANOSMIA / WP-2020-06
- Conditions
- Covid19
- Keywords
- Web-application, Anosmia, COVID-19, coaching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,155 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Kelindi, Centre National de la Recherche Scientifique, France, Hospital of Tours
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 Mar 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.
Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. However, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia In the context of the health crisis linked to the coronavirus, approximately 1 million French people will have persistent anosmia following an infection with COVID-19. A web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching.
covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users | – | Device: Web-applicationUsers of web-application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All users of the application who have not objected to the use of their data
Key inclusion criteria (2 listed)
- Post-COVID anosmia lasting more than 1 month
- Consent to the use of data via the application
Key exclusion criteria (3 listed)
- Other causes of anosmia than COVID
- Contraindication to olfactory coaching (allergy to one of the aromatic oils)
- Minor
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 |
|---|---|---|
| Web-applicationsupport for olfactory coaching consisting of the inhalation of fragrant essential oils. | Device | users |
Primary outcome
Evaluation of the rate of patients presenting an improvement in their anosmia
Time frame: 16 weeks
Number of patients with an improvement in anosmia (increase of at least 1 point on the visual analogue scale 0-10) on the number of users
3 secondary outcomes
Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,
Time frame: 16 weeks
Assessment of the duration of anosmia
Time frame: 16 weeks
Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils
Time frame: 16 weeks
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 11 Oct 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.
Fabrice DENIS, MD study director
Weprom
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 Covid19, run by Weprom 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 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 11 Oct 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?
Evaluation of the rate of patients presenting an improvement in their anosmia (time frame: 16 weeks). 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 11 Oct 2021.