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临床试验/NCT04657445
NCT04657445已完成不适用

EFFECT OF COVID-19 DISEASE IN SMELL AND TASTE OF PATIENTS WITH MILD, MODERATE OR SEVERE SYMPTOMATOLOGY

University Hospital, Ioannina1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
oflactory and taste dysfunction in SARS-CoV2 infection

研究概览

简要总结

This is an observational data and recording study. The aim of our study is to investigate the effect of SARS-COV2 infection on patients' sense of smell and taste, through quality control measurements using optic analogue scale (VAS) in hospitalized and in home-quarantined patients.

详细描述

Eligible participants who will be recruited in this research protocol will be adult patients who are diagnosed positive for SARS-COV2, infection with Real Time Polymerase Chain Reaction Test (RT-PCR).

The study population will be divided in two groups. The first group will be consisted with positive patients that were referred to either the Emergency Department (ED) of Infectious Diseases or at the Outpatient Clinic screening for SARS-COV2 and are being self-quarantined at home. The participants will be hospitalized patients in the Infectious Diseases Unit (IDU) of the University General Hospital of Ioannina.

The examination will be performed at the moment of diagnosis both for self-quarantine patients and for in hospitalized patients. The follow up evaluation will be a re-examination, performed at least four weeks after the moment of diagnosis. The time internal of reassessing the patients chosen according to current literature, estimated that is the minimum reassessment interval and seems to be a reference time for either progression stabilization or recession of the symptoms of anosmia/ ageusia (12, 13).

Patients will be asked to evaluate their olfactory and gustatory abilities through the visual analogue scale (VAS), at three time points: 1.before infection( as they can recall it), 2. at the time of diagnosis and 3. four weeks later(14).

Patients' scoring will be recorded in a horizontal presentation of 100 VAS points, where zero refers to no smell or taste while 100 refers to normal sensation. In addition, patients will rate their nasal obstruction and rhinorrhea on a similar VAS scale, where 0 refers to a completely blocked nose and an excessively runny nose while 100 indicates normal nasal breathing and a no runny nose. All patients will assess the intensity of the olfactory and taste function, through a self testing them at home. Patients will rate from 0 to 100 the intensity of smell, after being exposed to five common household odors (ie lemon juice, oregano, instant coffee, toothpaste and mint gum).The choice of these substances is based on their influence at the irritation of the trigeminal nerve.

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

  • adult>18 years old
  • COVID-19 positive patient, via RT-PCR test
  • Patient referred to the University General Hospital of Ioannina

排除标准

  • Previous nasal surgery, endoscopic sinus surgery
  • Head and neck radiotherapy
  • Head injury
  • Allergic rhinitis
  • Chronis Rhinosinusitis
  • Psychiatric/ Neurological disorders
  • Disorders that altering the level of consciousness (Glasgow Coma Scale <15)
  • History of smell and taste disorder

结局指标

主要结局

oflactory and taste dysfunction in SARS-CoV2 infection

时间窗: 4 WEEKS

次要结局

未报告次要终点

研究者

发起方
University Hospital, Ioannina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liontos Angelos

CONSULTANT OF INTERNAL MEDICINE

University Hospital, Ioannina

研究点 (1)

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