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

January 26, 2021 updated by: University of Milano Bicocca

Smell and Taste Disorders in COVID-19 Patients: Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy
        • ASST Monza-Ospedale San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until patient discharge from the hospital (approximately four months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until patient discharge from the hospital (approximately four months)
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
Until patient discharge from the hospital (approximately four months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

October 16, 2020

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 ORL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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