Malaysian COVID-19 Anosmia Study (Phase 2) - A Nationwide Multicentre Case-Control 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-29 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. Additionally, there is also limited evidence on the predictive value of screening for olfactory and taste disturbance in COVID-19 patients with subclinical symptoms.
The aim of this case-control study is to study the predictive value of screening for olfactory and taste disturbance in patients with COVID-19 infection in Malaysia. The cases will be selected from the cohort of COVID-19 positive patients recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country (from Phase 1 of the Malaysian COVID-19 Anosmia Study). Controls will be recruited from healthy volunteers who will will answer the an online questionnaire to evaluate and characterise their olfactory and taste symptoms. This is the same questionnaire that is answered by the COVID-19 patients in case cohort.
Dates
| Last Verified: | 04/30/2020 |
| First Submitted: | 05/09/2020 |
| Estimated Enrollment Submitted: | 05/09/2020 |
| First Posted: | 05/11/2020 |
| Last Update Submitted: | 05/11/2020 |
| Last Update Posted: | 05/13/2020 |
| 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: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Malaysian COVID-19 Cohort (Cases) A cohort of COVID-19 positive patients will be recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country. | |
| Healthy Volunteers (Controls) A cohort of age and sex-matched healthy volunteers will be recruited from participating Malaysian Ministry of Health-designated COVID-19 treating hospitals across the country. |
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. For Cases: 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. For Cases: Patients without a laboratory-confirmed COVID-19 diagnosis 3. For Cases: Patients in intensive care unit at the time of study |
Outcome
Primary Outcome Measures
1. Presence or absence of olfactory and taste disturbances in study participants [2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection]
2. Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection [2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection]
Secondary Outcome Measures
1. Clinical manifestations of study participants [2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection]
2. Other pre-existing health conditions [Baseline]
3. Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection [Baseline]
4. Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection [Baseline]
5. Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection [Baseline]
6. Specificity of olfactory and taste disturbances in predicting COVID-19 infection [Baseline]
