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Smell and Taste Disorders in COVID-19 Patients (COVID-19 ORL)

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ClinicalTrials.gov Identifier: NCT04427332
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:
This is a prospective monocentric observational study with the aim of investigating the demographic and clinical factors related to the smell and taste disorders in patients with Severe Acute Respiratory Syndrome - Coronavirus - 2 (Sars-Cov-2) infection.

Condition or disease Intervention/treatment
covid19 Other: Investigation of smell and taste disorders

Detailed Description:

BACKGROUND:

Preliminary observational data collected by Otorhinolaryngologist at the San Gerardo Hospital in Monza and by literature evidenced that numerous patients suffering from Sars-CoV-2 infection had smell and taste disorders. The are many data in the literature but few validated studies are available. Furthermore, it is not yet known in these patients what factors are related to the presence of olfactory and gustatory symptoms.

The aim of the study is to identify the demographic and clinical factors related to the smell and taste disorders in patients with Sars-CoV-2 infection, to evaluate the evolution of symptoms with a follow-up and to evaluate which factors influence the improvement of that symptoms.

STUDY DESIGN:

The study will include patients diagnosed with Sars-CoV-2 infection who have been hospitalized in the COVID wards of the San Gerardo Hospital in Monza and non-hospitalized patients but that get access to the "nasopharyngeal swabs" service of the hospital for the detection of the Sars-CoV-2 virus.

The study includes 3 timepoints. After acquiring informed consent, patient will be contacted on the phone and he will be asked to answer a multiple or short-answer questionnaire (T0) aimed at collecting demographic and clinical data, in particular relating to the smell and taste disorders, which will take place approximately 24 hours after running the swab. Follow-up period will follow, which will require patients to be contacted and invited by the Investigator to repeat the telephone questionnaire respectively 1 month (T1) and 3 months (T2) from the first compilation (T0).

The following information will be collected and recorded on a paper CRF:

  • registry collection (date of birth, gender at birth)
  • origin of the subjects: hospitalized, not hospitalized
  • pathological, pharmacological history, allergies, smoking, flu vaccination
  • date of onset of COVID19 symptoms
  • smell and taste symptoms and temporal correlation with systemic symptoms (fever, dyspnoea, headache, rhinitis, gastrointestinal symptoms, arthralgias, skin manifestations)
  • date of regression of the smell and taste symptoms

STATISCAL ANALYSIS:

A logistic regression model is used to identify what the clinical and demographic factors associated with the onset of the disease of interest are.

The composite endpoint consisting of the presence of smell and / or taste disorders vs the absence of both pathologies will be used as a variable. The secondary analyzes will concern only the subjects who have declared that they have had the disease in the study and, through a logistic or ordinal regression model, we will try to identify which factors are associated with the positive evolution of the disease at T3 compared to T0.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Smell and Taste Disorders in COVID-19 Patients: Prospective Observational Study
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Covid19 infection related patients
All subjects that had access to the "nasopharyngeal swabs" service of the hospital for the detection of the Sars-CoV-2 virus, both hospitalized and discharged from the hospital and not hospitalized, from mid-May to the end of June 2020, will be consecutively enrolled. It is assumed that 500 people will be recruited.
Other: Investigation of smell and taste disorders
The study consists of an epidemiological investigation by means of a prospective observational study with the aim of investigating the demographic and clinical factors related to the sense of smell and taste in patients with Sars Cov 2 infection.




Primary Outcome Measures :
  1. Identification of demographic and clinical factors in covid19 patients. [ Time Frame: Until patient discharge from the hospital (approximately four months) ]
    Identify the demographic and clinical factors related to the sense of smell and taste in patients with Sars-CoV-2 infection included in the study.


Secondary Outcome Measures :
  1. Description of the disturbances of smell and taste [ Time Frame: Until patient discharge from the hospital (approximately four months) ]
    Description in patients with Sars-CoV-2 infection the evolution of the symptoms (disturbances of smell and taste) understood as partial or total regression by 1-month and 3-month follow-up

  2. Description of factors that influence smell and taste [ Time Frame: Until patient discharge from the hospital (approximately four months). ]
    Define which factors (demographic and clinical) influence the improvement of the sense of smell and taste



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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 subjects belonging to the nasopharyngeal swabs service for the detection of the Sars-CoV-2 virus, both discharged from the hospital and not hospitalized, who will meet the inclusion / exclusion criteria, from mid-May until the end of June 2020 will be consecutively enrolled. It is assumed to recruit about 500 subjects.
Criteria

Inclusion Criteria:

  1. The study should include patients diagnosed of Sars-Cov-2 infection carried out at the San Gerardo Hospital of Monza:

    • discharged from the COVID + wards of the San Gerardo Hospital in Monza
    • not hospitalized subjected to nasopharyngeal swab for Sars-Cov-2 at the San Gerardo Hospital in Monza:
  2. Patients older than or equal to 18 years.
  3. The informed consent that will be freely granted and acquired before the start of the study.

Exclusion Criteria:

  1. Patients without ascertained diagnosis of Sars-Cov-2 infection carried out at San Gerardo Hospital in Monza;
  2. Patients with previous or current documented rhinosinusal pathologies, previous rhinosinusal surgery, previous cranio-facial trauma, previous neurosurgical and maxillofacial surgery interventions conditioning neurological or sensorineural deficits at the rhinosinusal level, neuropsychiatric pathologies.

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): NCT04427332


Contacts
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Contact: Dante Jean Garavello Werner Jean, Prof. 0392333626 werner.garavello@unimib.it

Locations
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Italy
ASST Monza-Ospedale San Gerardo Recruiting
Monza, Italy
Contact: Dante Jean Garavello Werner, Professor         
Sponsors and Collaborators
University of Milano Bicocca
Publications:

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04427332    
Other Study ID Numbers: COVID-19 ORL
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University of Milano Bicocca:
Coronavirus
sars-covid-2
coronavirus infection
Additional relevant MeSH terms:
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Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases