Smell and Taste Disorders in COVID-19 Patients

covid19 Clinical Trial

— COVID-19 ORL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427332
• Other study ID #: COVID-19 ORL
• Status: Completed
• Start date: June 11, 2020
• Est. completion date: October 16, 2020

Study information

• Verified date: January 2021
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• covid19
• Taste Disorders

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST Monza-Ospedale San Gerardo	Monza

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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, Hüttenbrink 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, Stjärne 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Nordin S, Brämerson 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of demographic and clinical factors in covid19 patients.	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	Description of the disturbances of smell and taste	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)
Secondary	Description of factors that influence smell and taste	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).