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

Sponsor
Weprom (Other)
Overall Status
Completed
CT.gov ID
NCT04806880
Collaborator
Kelindi (Industry), Centre National de la Recherche Scientifique, France (Other), Hospital of Tours (Other)
1,155
1
6.2
187

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Web-application

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1155 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
Actual Study Start Date :
Jan 25, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
users

Users of web-application

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the rate of patients presenting an improvement in their anosmia [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

Secondary Outcome Measures

  1. Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia, [16 weeks]

    Time between the date of first use of the application and the date of recovery of at least one point of anosmia

  2. Assessment of the duration of anosmia [16 weeks]

    Time between the date of diagnosis or onset of anosmia and the date of final recovery

  3. Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils [16 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ILC Le Mans France 72000

Sponsors and Collaborators

  • Weprom
  • Kelindi
  • Centre National de la Recherche Scientifique, France
  • Hospital of Tours

Investigators

  • Study Director: Fabrice DENIS, MD, Weprom

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weprom
ClinicalTrials.gov Identifier:
NCT04806880
Other Study ID Numbers:
  • WP-2020-06
First Posted:
Mar 19, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weprom
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021