Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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SARS-CoV Infection, COVID-19, Anosmia, Dysgeusia

Intervention / Treatment
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* Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malaysian COVID-19 Cohort<br>A cohort of COVID-19 positive patients will be recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country. | Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances<br>* This is an online patient-reported questionnaire that examines the presence or absence of olfactory and taste disturbances, the onset of olfactory and taste disturbances in relation to other COVID-19 symptoms, and the temporal evolution of the severity of olfactory and taste disturbances. The occurrence of ear symptoms in COVID-19 infection will also be evaluated in this questionnaire as a secondary outcome. The questionnaire will also have questions relating to the patient's underlying health conditions, risk factors for COVID-19 infection, and demographics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of olfactory and taste disturbances in COVID-19 patients | In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances | Within 2 weeks preceding the diagnosis of COVID-19 infection | 
| Prevalence of olfactory disturbances in COVID-19 patients | Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia) | Within 2 weeks preceding the diagnosis of COVID-19 infection | 
| Prevalence of taste disturbances in COVID-19 patients | Percentage of COVID-19 patients experiencing taste disturbances | Within 2 weeks preceding the diagnosis of COVID-19 infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical manifestations of study participants | In the patient-reported online questionnaire, subjects will be asked regarding other symptoms they experienced when they were diagnosed with COVID-19 (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms) | Within 2 weeks preceding the diagnosis of COVID-19 infection | 
| Other pre-existing health conditions | In the patient-reported online questionnaire, subjects will be asked regarding their pre-existing health conditions (for example, obesity, diabetes, hypertension, cardiac conditions, previous head trauma, chronic rhinosinusitis, etc.) | Prior to diagnosis of COVID-19 infection | 
| Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection | In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste before their diagnosis of COVID-19 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 | In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of diagnosis of COVID-19 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 | In the patient-reported online questionnaire, subjects will be asked to rate their sense of smell and taste at the time of answering questionnaire survey | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevalence, Cross-sectional study, Otorhinolaryngology, Infectious Diseases, Anosmia, Dysgeusia, Olfactory Disorders, Taste Disorders, COVID-19, SARS-CoV-2, Coronavirus 2019