Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection

NCT04354857 | Completed

• 1 other identifier: IRB: 20.04.09
• Study Type: observational
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of sense of smell and taste has been anecdotally reported during the covid-19 epidemic. The study investigators wanted to describe the prevalence of olfactory and gustatory dysfunction and assess the factors associated with positive SARS-CoV-2 infection.

Conditions

COVID-19

Keywords

anosmia; SARS-Cov-2

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 infection status

  Positive/negative according to RT-PCR assay

  Day 0

• Olfactory and gustatory loss

  Custom-designed questionnaire (28 questions pertaining to symptoms, sense of smell and taste)

  Day 0

Secondary Outcomes (12)

• Ability to detect odor

  Day 0

• Ability to detect odor

  Six months

• Ability to detect salty taste

  Day 0

• Ability to detect salty taste

  Six months

• Ability to detect sweet taste

  Day 0

Study Arms (2)

RT-PCR SARS-CoV-2 positive

Other: olfactory and gustatory tests

RT-PCR SARS-CoV-2 negative

Other: olfactory and gustatory tests

Interventions

olfactory and gustatory tests OTHER

Participants rate quality of sense of smell and taste. Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor. Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste

RT-PCR SARS-CoV-2 negative; RT-PCR SARS-CoV-2 positive

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 adults referred for a suspicion of COVID-19 infection and tested by RT-PCR assay for detection of SARS-CoV-2 in a nasopharyngeal sample at the COVID Screening Center or in the infectious and tropical diseases department of the University Hospital of Nîmes,

You may qualify if:

• Patients presenting with COVID-19 related symptoms including: fever, persistent cough, fatigue, shortness of breath, diarrhoea, abdominal pain, chest pain, sore throat, loss of smell or taste
• Subjects in prolonged contact with COVID-19 infected patients.

You may not qualify if:

• Patients directly admitted to the intensive care unit were excluded
• Patients opposing use of their health data

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Interventions

Smell

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Benjamin Lallemant

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: March 27, 2020
• Primary Completion: July 31, 2020
• Study Completion: November 30, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

FR (1)