NCT04390165

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 498 (actual)
• Sponsor: Hospital Sultanah Bahiyah · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-CoV Infection
• COVID-19
• Anosmia
• Dysgeusia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-06
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2020-05-15
• Last updated: 2021-02-25

Locations

14 sites across 1 country: Malaysia