Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Presence or absence of olfactory and taste disturbances in study participants
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 case-control study is described here (the cross-sectional 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-29 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. Additionally, there is also limited evidence on the predictive value of screening for olfactory and taste disturbance in COVID-19 patients with subclinical symptoms.
The aim of this case-control study is to study the predictive value of screening for olfactory and taste disturbance in patients with COVID-19 infection in Malaysia. The cases will be selected from the cohort of COVID-19 positive patients recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country (from Phase 1 of the Malaysian COVID-19 Anosmia Study). Controls will be recruited from healthy volunteers who will will answer the an online questionnaire to evaluate and characterise their olfactory and taste symptoms. This is the same questionnaire that is answered by the COVID-19 patients in case cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at least 18 years old
- •For Cases: 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
- •For Cases: Patients without a laboratory-confirmed COVID-19 diagnosis
- •For Cases: 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 study participants
时间窗: 2 weeks prior to answering questionnaire/ prior to 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
Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection
时间窗: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
The relationship between case \& control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.
次要结局
- Clinical manifestations of study participants(2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection)
- Other pre-existing health conditions(Baseline)
- Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection(Baseline)
- Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection(Baseline)
- Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection(Baseline)
- Specificity of olfactory and taste disturbances in predicting COVID-19 infection(Baseline)
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