Malaysian COVID-19 Anosmia Study (Phase 2) - A Nationwide Multicentre Case-Control Study
Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study
2 other identifiers
observational
60
1 country
14
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 case-control study is described here (the cross-sectional study is described in a separate ClinicalTrials.gov record).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2020
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
June 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedFebruary 25, 2021
February 1, 2021
10 months
May 10, 2020
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Presence or absence of olfactory and taste disturbances in study participants
In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances
2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection
The relationship between case \& control status and each exposure variable will be estimated by odds ratios and their 95% confidence intervals using conditional logistic regression models.
2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
Secondary Outcomes (6)
Clinical manifestations of study participants
2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
Other pre-existing health conditions
Baseline
Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection
Baseline
Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection
Baseline
Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection
Baseline
- +1 more secondary outcomes
Study Arms (2)
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.
Interventions
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
This study population will draw subjects from the cohort in Phase 1 of the Malaysian COVID-19 Anosmia Study (Nationwide Multicentre Cross-Sectional Study) as cases. These cases will comprise 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. The control subjects will be age and sex-matched healthy volunteers recruited from participating hospital sites in this study.
You may qualify if:
- Age at least 18 years old
- For Cases: Laboratory confirmed COVID-19 infection \[Reverse Transcription Polymerase Chain Reaction (RT-PCR)\]
- Patients clinically able to answer the questionnaire
You may not qualify if:
- Patients with olfactory or taste/gustatory disorders before the COVID-19 epidemic
- For Cases: Patients without a laboratory-confirmed COVID-19 diagnosis
- For Cases: Patients in intensive care unit at the time of study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Sultanah Bahiyahlead
- Hospital Tuanku Fauziah, Kangar, Perliscollaborator
- Penang Hospital, Malaysiacollaborator
- Hospital Raja Permaisuri Bainuncollaborator
- Hospital Sungai Buloh, Selangorcollaborator
- Kuala Lumpur General Hospitalcollaborator
- Hospital Tuanku Jaafar, Seremban, Negeri Sembilancollaborator
- Hospital Melaka, Melakacollaborator
- Hospital Enche Besar Hajjah Khalsom, Kluang, Johorcollaborator
- Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantancollaborator
- Hospital Sultanah Nur Zahirah, Kuala Terengganucollaborator
- Hospital Tengku Ampuan Afzan, Kuantan, Pahangcollaborator
- Sarawak General Hospitalcollaborator
- Hospital Queen Elizabeth, Malaysiacollaborator
Study Sites (14)
Hospital Enche' Besar Hajjah Khalsom
Kluang, Johor, 86000, Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05400, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15200, Malaysia
Hospital Tuanku Jaafar
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, 25100, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450, Malaysia
Hospital Tuanku Fauziah
Kangar, Perlis, 01000, Malaysia
Penang Hospital
George Town, Pulau Pinang, 10990, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, 88200, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, 47000, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, 20400, Malaysia
Kuala Lumpur General Hospital
Kuala Lumpur, 50586, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Related Publications (7)
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.
PMID: 31986264BACKGROUNDGiacomelli 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.
PMID: 32215618BACKGROUNDMao 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.
PMID: 32275288BACKGROUNDLechien 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.
PMID: 32253535BACKGROUNDKaye 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.
PMID: 32340555BACKGROUNDYan 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.
PMID: 32279441BACKGROUNDSpinato 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.
PMID: 32320008BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Siti Sabzah Mohd Hashim, MD MS
Hospital Sultanah Bahiyah
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Otorhinolaryngology Service, Ministry of Health, Malaysia & Senior Consultant Otorhinolaryngologist
Study Record Dates
First Submitted
May 10, 2020
First Posted
May 12, 2020
Study Start
June 6, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share