Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study
- Conditions
- COVID-19DysgeusiaSARS-CoV InfectionAnosmia
- Interventions
- Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
- Registration Number
- NCT04390165
- Lead Sponsor
- Hospital Sultanah Bahiyah
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Malaysian COVID-19 Cohort Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances A cohort of COVID-19 positive patients will be recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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
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
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
Trial Locations
- Locations (14)
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Kedah, Malaysia
Hospital Melaka
🇲🇾Melaka, Malaysia
Hospital Raja Perempuan Zainab II
🇲🇾Kota Bharu, Kelantan, Malaysia
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
Hospital Queen Elizabeth
🇲🇾Kota Kinabalu, Sabah, Malaysia
Hospital Sungai Buloh
🇲🇾Sungai Buloh, Selangor, Malaysia
Kuala Lumpur General Hospital
🇲🇾Kuala Lumpur, Malaysia
Hospital Enche' Besar Hajjah Khalsom
🇲🇾Kluang, Johor, Malaysia
Hospital Tuanku Fauziah
🇲🇾Kangar, Perlis, Malaysia
Hospital Tuanku Jaafar
🇲🇾Seremban, Negeri Sembilan, Malaysia
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Perak, Malaysia
Penang Hospital
🇲🇾George Town, Penang, Malaysia
Sarawak General Hospital
🇲🇾Kuching, Sarawak, Malaysia
Hospital Sultanah Nur Zahirah
🇲🇾Kuala Terengganu, Terengganu, Malaysia