Clinical trial NCT04427332: Smell and Taste Disorders in COVID-19 Patients
Official title: Smell and Taste Disorders in COVID-19 Patients: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: covid19
Keywords: Coronavirus
sars-covid-2
coronavirus infection
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Identification of demographic and clinical factors in covid19 patients.
timeFrame: Until patient discharge from the hospital (approximately four months)
Secondary outcomes:
measure: Description of the disturbances of smell and taste
timeFrame: Until patient discharge from the hospital (approximately four months)
measure: Description of factors that influence smell and taste
timeFrame: Until patient discharge from the hospital (approximately four months).
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST Monza-Ospedale San Gerardo
Study officials:
References:
citation: Baig AM. Neurological manifestations in COVID-19 caused by SARS-CoV-2. CNS Neurosci Ther. 2020 May;26(5):499-501. doi: 10.1111/cns.13372. Epub 2020 Apr 7. No abstract available.
citation: Hummel T, Whitcroft KL, Andrews P, Altundag A, Cinghi C, Costanzo RM, Damm M, Frasnelli J, Gudziol H, Gupta N, Haehne A, Holbrook E, Hong SC, Hornung D, Huttenbrink KB, Kamel R, Kobayashi M, Konstantinidis I, Landis BN, Leopold DA, Macchi A, Miwa T, Moesges R, Mullol J, Mueller CA, Ottaviano G, Passali GC, Philpott C, Pinto JM, Ramakrishnan VJ, Rombaux P, Roth Y, Schlosser RA, Shu B, Soler G, Stjarne P, Stuck BA, Vodicka J, Welge-Luessen A. Position paper on olfactory dysfunction. Rhinol Suppl. 2017 Mar;54(26):1-30. doi: 10.4193/Rhino16.248.
citation: Fonteyn S, Huart C, Deggouj N, Collet S, Eloy P, Rombaux P. Non-sinonasal-related olfactory dysfunction: A cohort of 496 patients. Eur Ann Otorhinolaryngol Head Neck Dis. 2014 Apr;131(2):87-91. doi: 10.1016/j.anorl.2013.03.006. Epub 2014 Mar 26.
citation: Klopfenstein T, Kadiane-Oussou NJ, Toko L, Royer PY, Lepiller Q, Gendrin V, Zayet S. Features of anosmia in COVID-19. Med Mal Infect. 2020 Aug;50(5):436-439. doi: 10.1016/j.medmal.2020.04.006. Epub 2020 Apr 17.
citation: Nordin S, Bramerson A. Complaints of olfactory disorders: epidemiology, assessment and clinical implications. Curr Opin Allergy Clin Immunol. 2008 Feb;8(1):10-5. doi: 10.1097/ACI.0b013e3282f3f473.
citation: Li YC, Bai WZ, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020 Jun;92(6):552-555. doi: 10.1002/jmv.25728. Epub 2020 Mar 11.
citation: Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
citation: Galluzzi F, Rossi V, Bosetti C, Garavello W. Risk Factors for Olfactory and Gustatory Dysfunctions in Patients with SARS-CoV-2 Infection. Neuroepidemiology. 2021;55(2):154-161. doi: 10.1159/000514888. Epub 2021 Apr 1.