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临床试验/NCT04390165
NCT04390165已完成不适用

Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Cross-Sectional Study

Hospital Sultanah Bahiyah14 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2020年6月6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
498
试验地点
14
主要终点
Presence or absence of olfactory and taste disturbances in COVID-19 patients

研究概览

简要总结

The Malaysian COVID-19 Anosmia Study is a nationwide multicentre observational study to investigate the prevalence and characteristics of olfactory and gustatory/taste disturbances in COVID-19 infection in Malaysia, and to evaluate the predictive value of screening for these symptoms in COVID-19 infection.

This study consists of two phases: the first phase is a cross-sectional study and the second phase is a case-control study. The cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).

详细描述

The world is currently in the midst of the Coronavirus 2019 (COVID-19) pandemic that is caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). According to published cohort studies on COVID-19 infected patients, the most prevalent symptoms consist of fever, dry cough, dyspnoea, sputum production, myalgia, arthralgia, headache, diarrhoea, and sore throat. Recently, there have been concerns of significant viral transmission through asymptomatic, pre-symptomatic or even mildly symptomatic patients.

There is increasing anecdotal evidence from patients and healthcare professionals highlighting isolated loss of sense of smell (anosmia) and taste disturbances (dysgeusia) as atypical symptoms of COVID-19 infection in otherwise asymptomatic patients. In parallel, expert statements from the British Association of Otorhinolaryngology-Head & Neck Surgery (ENT UK), British Rhinological Society, and the American Association of Otolaryngology-Head & Neck Surgery (AAO-HNS) have suggested that olfactory and taste disturbances could be a clinical feature of COVID-19 infection.

Rapidly emerging evidence from Europe, the United Kingdom and the United States have found olfactory and taste disturbances to be highly prevalent in patients diagnosed with COVID-19. In contrast, there is currently limited evidence from Asia on the prevalence of these symptoms in COVID-19 infection.

The aim of this cross-sectional study is to study the prevalence and characteristics of olfactory and taste disturbance in patients with COVID-19 infection in Malaysia. COVID-19 positive patients will be recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country. Participants will answer an online questionnaire to evaluate and characterise these symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Age at least 18 years old
  • Laboratory confirmed COVID-19 infection [Reverse Transcription Polymerase Chain Reaction (RT-PCR)]
  • Patients clinically able to answer the questionnaire

排除标准

  • Patients with olfactory or taste/gustatory disorders before the COVID-19 epidemic
  • Patients without a laboratory-confirmed COVID-19 diagnosis
  • Patients in intensive care unit at the time of study

结局指标

主要结局

Presence or absence of olfactory and taste disturbances in COVID-19 patients

时间窗: Within 2 weeks preceding the diagnosis of COVID-19 infection

In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances

Prevalence of olfactory disturbances in COVID-19 patients

时间窗: Within 2 weeks preceding the diagnosis of COVID-19 infection

Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)

Prevalence of taste disturbances in COVID-19 patients

时间窗: Within 2 weeks preceding the diagnosis of COVID-19 infection

Percentage of COVID-19 patients experiencing taste disturbances

次要结局

  • Clinical manifestations of study participants(Within 2 weeks preceding the diagnosis of COVID-19 infection)
  • Other pre-existing health conditions(Prior to diagnosis of COVID-19 infection)
  • Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection(Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline))
  • Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection(Within 2 weeks preceding the diagnosis of COVID-19 infection)
  • Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey(Up to 6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Siti Sabzah bt Mohd Hashim, MD, MS (ORL-HNS)

Head of Otorhinolaryngology Service, Ministry of Health, Malaysia & Senior Consultant Otorhinolaryngologist

Hospital Sultanah Bahiyah

研究点 (14)

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