Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Malaysian COVID-19 Cohort 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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age at least 18 years old
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Laboratory confirmed COVID-19 infection [Reverse Transcription Polymerase Chain Reaction (RT-PCR)]
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Patients clinically able to answer the questionnaire
Exclusion Criteria:
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Patients with olfactory or taste/gustatory disorders before the COVID-19 epidemic
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Patients without a laboratory-confirmed COVID-19 diagnosis
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Patients in intensive care unit at the time of study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Enche' Besar Hajjah Khalsom | Kluang | Johor | Malaysia | 86000 |
| 2 | Hospital Sultanah Bahiyah | Alor Setar | Kedah | Malaysia | 05400 |
| 3 | Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | Malaysia | 15200 |
| 4 | Hospital Tuanku Jaafar | Seremban | Negeri Sembilan | Malaysia | 70300 |
| 5 | Hospital Tengku Ampuan Afzan | Kuantan | Pahang | Malaysia | 25100 |
| 6 | Penang Hospital | George Town | Penang | Malaysia | 10990 |
| 7 | Hospital Raja Permaisuri Bainun | Ipoh | Perak | Malaysia | 30450 |
| 8 | Hospital Tuanku Fauziah | Kangar | Perlis | Malaysia | 01000 |
| 9 | Hospital Queen Elizabeth | Kota Kinabalu | Sabah | Malaysia | 88200 |
| 10 | Sarawak General Hospital | Kuching | Sarawak | Malaysia | 93586 |
| 11 | Hospital Sungai Buloh | Sungai Buloh | Selangor | Malaysia | 47000 |
| 12 | Hospital Sultanah Nur Zahirah | Kuala Terengganu | Terengganu | Malaysia | 20400 |
| 13 | Kuala Lumpur General Hospital | Kuala Lumpur | Malaysia | 50586 | |
| 14 | Hospital Melaka | Melaka | Malaysia | 75400 |
Sponsors and Collaborators
- Hospital Sultanah Bahiyah
- 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, Terengganu
- Hospital Tengku Ampuan Afzan, Kuantan, Pahang
- Sarawak General Hospital
- Hospital Queen Elizabeth, Malaysia
Investigators
- Study Chair: Siti Sabzah Mohd Hashim, MD MS, Hospital Sultanah Bahiyah
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Giacomelli A, Pezzati L, Conti F, Bernacchia D, Siano M, Oreni L, Rusconi S, Gervasoni C, Ridolfo AL, Rizzardini G, Antinori S, Galli M. Self-reported Olfactory and Taste Disorders in Patients With Severe Acute Respiratory Coronavirus 2 Infection: A Cross-sectional Study. Clin Infect Dis. 2020 Jul 28;71(15):889-890. doi: 10.1093/cid/ciaa330.
- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.
- Kaye R, Chang CWD, Kazahaya K, Brereton J, Denneny JC 3rd. COVID-19 Anosmia Reporting Tool: Initial Findings. Otolaryngol Head Neck Surg. 2020 Jul;163(1):132-134. doi: 10.1177/0194599820922992. Epub 2020 Apr 28. Review.
- Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
- Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
- Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771.
- Yan CH, Faraji F, Prajapati DP, Boone CE, DeConde AS. Association of chemosensory dysfunction and COVID-19 in patients presenting with influenza-like symptoms. Int Forum Allergy Rhinol. 2020 Jul;10(7):806-813. doi: 10.1002/alr.22579. Epub 2020 Jun 1.
- MCO-001
- NMRR-20-934-54803