Smell and Taste Disorders in COVID-19 Patients

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.