An observational study in SARS-CoV Infection, COVID-19 and Anosmia, sponsored by Hospital Sultanah Bahiyah. Completed at 14 sites in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Hospital Sultanah Bahiyah · Observational
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).
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.
376 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 15 are open to participants now.
This study's enrollment of 498 is above the median of 300 across 129 observational studies indexed under Severe Acute Respiratory Syndrome.
Browse Severe Acute Respiratory Syndrome studies →Hospital Sultanah Bahiyah is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population are adult patients with laboratory-confirmed COVID-19 infection from participating Malaysian hospital sites in this study, since the arrival of COVID-19 infection in Malaysia (January 2020) until present time.
These patients comprise those who either currently inpatient or already discharged into the community. For patients already discharged into the community, they will be invited to participate by phone call from the hospital treating team. Once verbal consent has been obtained, they a QR code or internet URL link to the online questionnaire website will be sent to these patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: 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.
Presence or absence of olfactory and taste disturbances in COVID-19 patients
In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
Time frame: Within 2 weeks preceding the diagnosis of COVID-19 infection
Prevalence of olfactory disturbances in COVID-19 patients
Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)
Time frame: Within 2 weeks preceding the diagnosis of COVID-19 infection
Prevalence of taste disturbances in COVID-19 patients
Percentage of COVID-19 patients experiencing taste disturbances
Time frame: Within 2 weeks preceding the diagnosis of COVID-19 infection
Clinical manifestations of study participants
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)
Time frame: Within 2 weeks preceding the diagnosis of COVID-19 infection
Other pre-existing health conditions
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.)
Time frame: Prior to diagnosis of COVID-19 infection
Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection
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
Time frame: Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)
Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their 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
Time frame: Within 2 weeks preceding the diagnosis of COVID-19 infection
Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey
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
Time frame: Up to 6 months
Plan to share: No
Ran from Jun 2020 to primary completion in Nov 2020, 5 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Severe Acute Respiratory Syndrome →
Hospital Sultanah Bahiyah