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

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

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.

Completed
SARS-CoV Infection
COVID-19
Anosmia
Dysgeusia

Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances

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.

Eligibility Criteria

Inclusion Criteria:

1. Age at least 18 years old

2. Laboratory confirmed COVID-19 infection [Reverse Transcription Polymerase Chain
Reaction (RT-PCR)]

3. Patients clinically able to answer the questionnaire

Exclusion Criteria:

1. Patients with olfactory or taste/gustatory disorders before the COVID-19 epidemic

2. Patients without a laboratory-confirmed COVID-19 diagnosis

3. Patients in intensive care unit at the time of study

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Malaysia
Locations

Hospital Enche' Besar Hajjah Khalsom
Kluang, Johor, Malaysia

Hospital Sultanah Bahiyah
Alor Setar, Kedah, Malaysia

Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia

Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, Malaysia

Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia

Penang Hospital
George Town, Penang, Malaysia

Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia

Hospital Tuanku Fauziah
Kangar, Perlis, Malaysia

Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia

Sarawak General Hospital
Kuching, Sarawak, Malaysia

Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia

Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, Malaysia

Kuala Lumpur General Hospital
Kuala Lumpur, Malaysia

Hospital Melaka
Melaka, Malaysia

Siti Sabzah Mohd Hashim, MD MS, Study Chair
Hospital Sultanah Bahiyah

Hospital Sultanah Bahiyah
NCT Number
Keywords
Cross-sectional study
Prevalence
otorhinolaryngology
infectious diseases
anosmia
Dysgeusia
Olfactory Disorders
Taste Disorders
Covid-19
SARS-CoV-2
Coronavirus 2019
MeSH Terms
Infections
COVID-19
Severe Acute Respiratory Syndrome
Anosmia
Dysgeusia