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

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ClinicalTrials.gov Identifier: NCT04354857
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment
COVID-19 Other: olfactory and gustatory tests

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Study Type : Observational
Estimated Enrollment : 454 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative and Quantitative Evaluation of Anosmia Over Time in Clinically Symptomatic Patients Tested for COVID-19 Infection
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : November 2020

Group/Cohort Intervention/treatment
RT-PCR SARS-CoV-2 positive Other: olfactory and gustatory tests

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 Other: olfactory and gustatory tests

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 Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354857


Contacts
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Contact: Benjamin Lallemant 04.66.68.32.73 benjamin.lallemant@chu-nimes.fr

Locations
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France
CHU de Nimes Recruiting
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Benjamin Lallemant         
Sub-Investigator: Caroline Alovisetti         
Sub-Investigator: Jean-Philippe Lavigne         
Sub-Investigator: Didier Laureillard         
Sub-Investigator: Albert Sotto         
Sub-Investigator: Paul Loubet         
Sub-Investigator: Gaelle Regnier         
Sub-Investigator: Marie-José Carles         
Sub-Investigator: Robin Stephan         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Benjamin Lallemant CHU Nimes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04354857    
Other Study ID Numbers: IRB: 20.04.09
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
anosmia
SARS-Cov-2
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases