Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application

Covid19 Clinical Trial

— COVIDANOSMIA  

Official title:

Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806880
• Other study ID #: WP-2020-06
• Status: Completed
• Start date: January 25, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Covid19

Intervention

Device:
• Web-application
support for olfactory coaching consisting of the inhalation of fragrant essential oils.

Locations

Country	Name	City	State
France	ILC	Le Mans

Sponsors (4)

Lead Sponsor	Collaborator
Weprom	Centre National de la Recherche Scientifique, France, Hospital of Tours, Kelindi

Country where clinical trial is conducted

France, 

Outcome

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