NCT04681157

Brief Summary

Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss. The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 22, 2020

Last Update Submit

December 23, 2020

Conditions

Keywords

Covid-19Odor disturbanceTaste disturbancesSARS-Cov2AnosmiaAgeusia

Outcome Measures

Primary Outcomes (1)

  • Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia

    The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19

You may qualify if:

  • Major subject (≥18 years old)
  • Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
  • Subject with suspected or confirmed Covid-19 infection
  • Subject taken care of by the ENT service
  • Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

You may not qualify if:

  • Subject having expressed opposition to participating in the study
  • Subject under guardianship or guardianship
  • Subject under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strasbourg University Hospitals - Otorhino-Laryngology Department

Strasbourg, Starsbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19DysgeusiaAnosmiaAgeusia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTaste DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOlfaction Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 23, 2020

Study Start

April 3, 2020

Primary Completion

April 3, 2021

Study Completion

April 3, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Locations