Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 05/09/2020 |
| Estimated Enrollment Submitted: | 05/12/2020 |
| First Posted: | 05/14/2020 |
| Last Update Submitted: | 05/12/2020 |
| Last Update Posted: | 05/14/2020 |
| Actual Study Start Date: | 04/30/2020 |
| Estimated Primary Completion Date: | 06/30/2020 |
| Estimated Study Completion Date: | 07/31/2020 |
Condition or disease
Intervention/treatment
Other: Malaysian COVID-19 Cohort
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Malaysian COVID-19 Cohort 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: Malaysian COVID-19 Cohort 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
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Presence or absence of olfactory and taste disturbances in COVID-19 patients [Within 2 weeks preceding the diagnosis of COVID-19 infection]
2. Prevalence of olfactory disturbances in COVID-19 patients [Within 2 weeks preceding the diagnosis of COVID-19 infection]
3. Prevalence of taste disturbances in COVID-19 patients [Within 2 weeks preceding the diagnosis of COVID-19 infection]
Secondary Outcome Measures
1. Clinical manifestations of study participants [Within 2 weeks preceding the diagnosis of COVID-19 infection]
2. Other pre-existing health conditions [Prior to diagnosis of COVID-19 infection]
3. 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)]
4. 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]
5. Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey [Up to 6 months]
