Smell and Taste Disorders in COVID-19 Patients

NCT04427332 | Completed DMC

• 1 other identifier: COVID-19 ORL
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

covid19

Keywords

Coronavirus; sars-covid-2; coronavirus infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Description of the disturbances of smell and taste

  Until patient discharge from the hospital (approximately four months)

• Description of factors that influence smell and taste

  Until patient discharge from the hospital (approximately four months).

Study Arms (1)

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

Interventions

Investigation of smell and taste disorders OTHER

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.

Covid19 infection related patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Patients older than or equal to 18 years.
• The informed consent that will be freely granted and acquired before the start of the study.

You may not qualify if:

• Patients without ascertained diagnosis of Sars-Cov-2 infection carried out at San Gerardo Hospital in Monza;
• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST Monza-Ospedale San Gerardo

Monza, Italy

Location

Related Publications (8)

• 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.

  PMID: 32266761 BACKGROUND

• 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.

  PMID: 29528615 BACKGROUND

• 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.

  PMID: 24679542 BACKGROUND

• 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.

  PMID: 32305563 BACKGROUND

• 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.

  PMID: 18188011 BACKGROUND

• 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.

  PMID: 32104915 BACKGROUND

• 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.

  PMID: 32275288 BACKGROUND

• 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.

  PMID: 33794531 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: June 11, 2020
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)