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临床试验/NCT04427332
NCT04427332已完成不适用

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

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
376
试验地点
1
主要终点
Identification of demographic and clinical factors in covid19 patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Identification of demographic and clinical factors in covid19 patients.

时间窗: 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.

次要结局

  • Description of factors that influence smell and taste(Until patient discharge from the hospital (approximately four months).)
  • Description of the disturbances of smell and taste(Until patient discharge from the hospital (approximately four months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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