Covid19 Clinical Trial
— COVIDANOSMIAOfficial title:
Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
NCT number | NCT04806880 |
Other study ID # | WP-2020-06 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 25, 2021 |
Est. completion date | August 1, 2021 |
Verified date | March 2021 |
Source | Weprom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 1155 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Post-COVID anosmia lasting more than 1 month - Consent to the use of data via the application Exclusion Criteria: - Other causes of anosmia than COVID - Contraindication to olfactory coaching (allergy to one of the aromatic oils) - Minor |
Country | Name | City | State |
---|---|---|---|
France | ILC | Le Mans |
Lead Sponsor | Collaborator |
---|---|
Weprom | Centre National de la Recherche Scientifique, France, Hospital of Tours, Kelindi |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 16 weeks | |
Secondary | 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 | 16 weeks | |
Secondary | Assessment of the duration of anosmia | Time between the date of diagnosis or onset of anosmia and the date of final recovery | 16 weeks | |
Secondary | 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 | 16 weeks |
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