Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study
NCT ID: NCT04390165
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
498 participants
OBSERVATIONAL
2020-06-06
2020-11-30
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Laboratory confirmed COVID-19 infection \[Reverse Transcription Polymerase Chain Reaction (RT-PCR)\]
3. Patients clinically able to answer the questionnaire
Exclusion Criteria
2. Patients without a laboratory-confirmed COVID-19 diagnosis
3. Patients in intensive care unit at the time of study
18 Years
ALL
No
Sponsors
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Hospital Tuanku Fauziah, Kangar, Perlis
UNKNOWN
Penang Hospital, Malaysia
OTHER_GOV
Hospital Raja Permaisuri Bainun
OTHER_GOV
Hospital Sungai Buloh, Selangor
UNKNOWN
Kuala Lumpur General Hospital
OTHER_GOV
Hospital Tuanku Jaafar, Seremban, Negeri Sembilan
UNKNOWN
Hospital Melaka, Melaka
UNKNOWN
Hospital Enche Besar Hajjah Khalsom, Kluang, Johor
UNKNOWN
Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan
UNKNOWN
Hospital Sultanah Nur Zahirah, Kuala Terengganu
OTHER_GOV
Hospital Tengku Ampuan Afzan, Kuantan, Pahang
UNKNOWN
Sarawak General Hospital
OTHER
Hospital Queen Elizabeth, Malaysia
OTHER_GOV
Hospital Sultanah Bahiyah
OTHER_GOV
Responsible Party
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Siti Sabzah bt Mohd Hashim, MD, MS (ORL-HNS)
Head of Otorhinolaryngology Service, Ministry of Health, Malaysia & Senior Consultant Otorhinolaryngologist
Principal Investigators
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Siti Sabzah Mohd Hashim, MD MS
Role: STUDY_CHAIR
Hospital Sultanah Bahiyah
Locations
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Hospital Enche' Besar Hajjah Khalsom
Kluang, Johor, Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Tuanku Fauziah
Kangar, Perlis, Malaysia
Penang Hospital
George Town, Pulau Pinang, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, Malaysia
Kuala Lumpur General Hospital
Kuala Lumpur, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Countries
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References
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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.
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. No abstract available.
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.
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.
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.
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.
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.
Lee SH, Yeoh ZX, Sachlin IS, Gazali N, Soelar SA, Foo CY, Low LL, Syed Alwi SB, Tengku Kamalden TMI, Shanmuganathan J, Zaid M, Wong CY, Chua HH, Yusuf S, Muhamad D, Devesahayam PR, Ker HB, Salahuddin Z, Mustafa M, Sawali H, Lee HG, Din S, Misnan NA, Mohamad A, Ismail MN, Periasamy C, Chow TS, Krishnan EK, Leong CL, Lim LPF, Zaidan NZ, Ibrahim MZ, Abd Wahab S, Mohd Hashim SS; Malaysian COVID-19 Anosmia Research Group. Self-reported symptom study of COVID-19 chemosensory dysfunction in Malaysia. Sci Rep. 2022 Feb 8;12(1):2111. doi: 10.1038/s41598-022-06029-6.
Related Links
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AAO-HNS: Anosmia, Hyposmia, and Dysgeusia Symptoms of Coronavirus Disease \| American Academy of Otolaryngology-Head and Neck Surgery
Other Identifiers
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NMRR-20-934-54803
Identifier Type: OTHER
Identifier Source: secondary_id
MCO-001
Identifier Type: -
Identifier Source: org_study_id
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