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Completed

NCT Number: NCT04354857

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

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.

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Key information

Conditions

COVID-19 Anosmia Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. SARS-CoV-2 infection status

    Time frame: Day 0

    Positive/negative according to RT-PCR assay

  2. Olfactory and gustatory loss

    Time frame: Day 0

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

Secondary outcomes

  1. Ability to detect odor

    Time frame: Day 0

    Ability to smell 1.5ml air freshner on a 0-100 VAS scale

  2. Ability to detect odor

    Time frame: Six months

    Ability to smell 1.5ml air freshner on a 0-100 VAS scale

  3. Ability to detect salty taste

    Time frame: Day 0

    Ability to taste a pinch of table salt on a 0-100 VAS scale

  4. Ability to detect salty taste

    Time frame: Six months

    Ability to taste a pinch of table salt on a 0-100 VAS scale

  5. Ability to detect sweet taste

    Time frame: Day 0

    Ability to taste a pinch of sugar on a 0-100 VAS scale

  6. Ability to detect sweet taste

    Time frame: Six months

    Ability to taste a pinch of sugar on a 0-100 VAS scale

  7. Olfactory and gustatory loss

    Time frame: Day 7

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

  8. Olfactory and gustatory loss

    Time frame: Day 14

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

  9. Olfactory and gustatory loss

    Time frame: Day 30

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

  10. Olfactory and gustatory loss

    Time frame: Day 60

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

  11. Severity of infection according to hospitalization rate

    Time frame: End of study (six months)

    % patients hospitalized

  12. Olfactory and gustatory loss

    Time frame: Six months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: Anosmie-COVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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