Anosmia, COVID-19, Dysgeusia, SARS-CoV Infection
Conditions
Keywords
Cross-sectional study, Prevalence, Otorhinolaryngology, Infectious Diseases, Anosmia, Dysgeusia, Olfactory Disorders, Taste Disorders, COVID-19, SARS-CoV-2, Coronavirus 2019
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.
Interventions
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.
Sponsors
Hospital Tuanku Fauziah, Kangar, Perlis
Penang Hospital, Malaysia
Hospital Raja Permaisuri Bainun
Hospital Sungai Buloh, Selangor
Kuala Lumpur General Hospital
Hospital Tuanku Jaafar, Seremban, Negeri Sembilan
Hospital Melaka, Melaka
Hospital Enche Besar Hajjah Khalsom, Kluang, Johor
Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan
Hospital Sultanah Nur Zahirah, Kuala Terengganu
Hospital Tengku Ampuan Afzan, Kuantan, Pahang
Sarawak General Hospital
Hospital Queen Elizabeth, Malaysia
Hospital Sultanah Bahiyah
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of olfactory and taste disturbances in COVID-19 patients | Within 2 weeks preceding the 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 |
| Prevalence of olfactory disturbances in COVID-19 patients | Within 2 weeks preceding the diagnosis of COVID-19 infection | Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia) |
| Prevalence of taste disturbances in COVID-19 patients | Within 2 weeks preceding the diagnosis of COVID-19 infection | Percentage of COVID-19 patients experiencing taste disturbances |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Clinical manifestations of study participants | Within 2 weeks preceding the diagnosis of COVID-19 infection | 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) |
| Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey | Up to 6 months | 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 |
| Other pre-existing health conditions | Prior to diagnosis of COVID-19 infection | 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.) |
| 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) | 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 |
Countries
Malaysia
Outcome results
None listed