COVID-19: Post-covid Olfactory Disorders Assessment

NCT04799977 | Completed

• 1 other identifier: 21IUFCcovid01
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.

Conditions

Olfaction Disorders

Outcome Measures

Primary Outcomes (1)

• Sniffin Stick Tests (score TDI)

  The subjective olfactory losses and recoveries are most often evaluated using the "Sniffin 'Sticks Test®", the current gold standard of objective olfactory tests allowing in a single examination to group together: the definition of an olfactory threshold, olfactory discrimination and olfactory identification in the form of an overall TDI score. Olfactory function using psychophysical tests before and after treatment or specific cares : Sniffin Stick Tests (score TDI). Results can classified patients in Anosmic (TDI\<16,25), Hyposmic (16,25\<TDI\<30,75) and Normosmic (TDI\>30,75). Higher score = better results. Minimal clinically important difference = 5,5.

  12 months : Evalation at the beginning and the end.

Secondary Outcomes (13)

• Hamilton Depression Rating Scale (HDRS)

  12 months : Evaluation at the beginning and the end.

• Situational anxiety and anxiety trait inventory (STAI-Y)

  12 months : Evaluation at the beginning and the end.

• PTSD checklist for DSM-5 (PCL-5)

  12 months : Evaluation at the beginning and the end.

• GREMOTS

  12 months : Evaluation at the beginning and the end.

• PPT

  12 months : Evaluation at the beginning and the end.

Study Arms (2)

COVID19 infection with olfaction disorder

Patients, ≥18 ans, who suffered from an olfaction disorder while going through a COVID19 infection

COVID19 infection without olfaction disorder

Patients, ≥18 ans, who suffered from a COVID19 infection without any olfaction disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who presented with anosmia during their COVID19 infection (proven by a PCR+ test) and presenting at the ENT department consultation in university hospital more than 6 weeks after the end of symptoms,

You may qualify if:

• Adults patient,
• anosmia during a COVID19 acute infection (PCR+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared.

You may not qualify if:

• preexisting smell loss.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

IUFC

Nice, 06100, France

Location

Related Publications (1)

• Dumas LE, Vandersteen C, Metelkina-Fernandez V, Gros A, Auby P, Askenazy-Gittard F. Impact of post-COVID-19 olfactory disorders on quality of life, hedonic experiences and psychiatric dimensions in general population. BMC Psychiatry. 2024 Feb 8;24(1):111. doi: 10.1186/s12888-024-05538-0.

  PMID: 38331799 DERIVED

MeSH Terms

Conditions

Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 16, 2021
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 22, 2025

Record last verified: 2021-04

Locations

FR (1)