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Malaysian COVID-19 Anosmia Study (Phase 2) - A Nationwide Multicentre Case-Control Study

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ClinicalTrials.gov Identifier: NCT04384042
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Siti Sabzah bt Mohd Hashim, MD, MS (ORL-HNS), Hospital Sultanah Bahiyah

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).


Condition or disease Intervention/treatment
SARS-CoV Infection COVID-19 Anosmia Dysgeusia Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances

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-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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Case-Control Study
Actual Study Start Date : June 6, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Group/Cohort 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.
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.

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.
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.




Primary Outcome Measures :
  1. Presence or absence of olfactory and taste disturbances in study participants [ Time Frame: 2 weeks prior to answering questionnaire/ prior to 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

  2. Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection [ Time Frame: 2 weeks prior to answering questionnaire/ prior to diagnosis of 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.


Secondary Outcome Measures :
  1. Clinical manifestations of study participants [ Time Frame: 2 weeks prior to answering questionnaire/ prior to 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/within the past 2 weeks of answering the questionnaire (e.g. headache, nasal congestion, fever, chills, cough, dyspnoea, gastrointestinal symptoms, eye & ear symptoms)

  2. Other pre-existing health conditions [ Time Frame: Baseline ]
    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.)

  3. Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection [ Time Frame: Baseline ]
    PPV reflects the probability that the presence of olfactory and taste disturbances will have a positive diagnosis of COVID-19. This is derived from dividing the number of patients with olfactory & taste disturbances with COVID-19 infection over the total number of patients with olfactory and taste disturbances, and multiplying by 100%

  4. Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection [ Time Frame: Baseline ]
    NPV reflects the probability that the absence of olfactory and taste disturbances will have a negative diagnosis of COVID-19. This is derived from dividing the number of patients without olfactory & taste disturbances and without COVID-19 infection over the total number of patients with no olfactory and taste disturbances, and multiplying by 100%

  5. Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection [ Time Frame: Baseline ]
    The percentage of true positives, i.e. the proportion of patients with olfactory and taste disorders with COVID-19 infection. This can be calculated by dividing the number of subjects with olfactory & taste disturbances who have COVID-19 infection with the number of patients with olfactory & taste disturbances, and multiplying by 100%

  6. Specificity of olfactory and taste disturbances in predicting COVID-19 infection [ Time Frame: Baseline ]
    The percentage of true negatives, i.e. the proportion of patients without olfactory and taste disorders who do not have COVID-19 infection. This can be calculated by dividing the number of subjects without olfactory & taste disturbances who do not have COVID-19 infection with the number of patients without olfactory & taste disturbances, and multiplying by 100%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384042


Contacts
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Contact: Siti Sabzah Mohd Hashim, MD MS +604 740 7335 dr_ctsabzah@yahoo.com
Contact: Shen-Han Lee, MB PhD MRCS +6016 474 0088 shen-han.lee@cantab.net

Locations
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Malaysia
Hospital Enche' Besar Hajjah Khalsom Recruiting
Kluang, Johor, Malaysia, 86000
Contact: Jothi Shanmuganathan, MBBS MMed         
Principal Investigator: Jothi Shanmuganathan, MBBS MMed         
Sub-Investigator: Masliza Zaid, MBBS MMed         
Principal Investigator: Tengku Mohamed Izam Tengku Kamalden, MD MS FRCS         
Hospital Sultanah Bahiyah Recruiting
Alor Setar, Kedah, Malaysia, 05400
Contact: Siti Sabzah Mohd Hashim, MD MS         
Contact: Shen-Han Lee, MB PhD MRCS         
Principal Investigator: Siti Sabzah Mohd Hashim, MD MS         
Sub-Investigator: Norzi Gazali, MBBS MMed         
Sub-Investigator: Ida Sadja'ah Sachlin, MBBS MMed         
Sub-Investigator: Zhi Xiang Yeoh, MBBS MS MRCS         
Sub-Investigator: Shen-Han Lee, MB PhD MRCS         
Sub-Investigator: Lee Lee Low, MD MRCP         
Sub-Investigator: Sharifah Baizura Syed Alwi, MD MRCPI         
Sub-Investigator: Shahrul Aiman Soelar, B Ind Stats         
Sub-Investigator: Ibtisam Ismail, BSc         
Hospital Raja Perempuan Zainab II Recruiting
Kota Bharu, Kelantan, Malaysia, 15200
Contact: Zulkiflee Salahuddin, MD MS         
Principal Investigator: Zulkiflee Salahuddin, MD MS         
Sub-Investigator: Rosdi Ramli, MBBS MMed         
Sub-Investigator: Mahiran Mustafa, MBBCh MMed         
Sub-Investigator: Anilawati Mat Jelani, MD MMed         
Sub-Investigator: Rosli Mohd Noor, MD MMed         
Hospital Tuanku Jaafar Recruiting
Seremban, Negeri Sembilan, Malaysia, 70300
Contact: Jeyasakthy Saniasiaya, MMed FEBORL         
Principal Investigator: Jeyasakthy Saniasiaya, MMed FEBORL         
Sub-Investigator: Tiang Koi Ng, MBBS MRCP         
Hospital Tengku Ampuan Afzan Recruiting
Kuantan, Pahang, Malaysia, 25100
Contact: Suhaimi Yusuf, MBBS MMed         
Principal Investigator: Suhaimi Yusof, MBBS MMed         
Sub-Investigator: Dzawani Muhamad, MD MMed         
Penang Hospital Recruiting
George Town, Penang, Malaysia, 10990
Contact: Chenthilnathan Periasamy, MBBS MMed         
Principal Investigator: Chenthilnathan Periasamy, MBBS MMed         
Sub-Investigator: Ting Soo Chow, MD MRCP         
Hospital Raja Permaisuri Bainun Recruiting
Ipoh, Perak, Malaysia, 30450
Contact: Philip Rajan Devesahayam, MMed FRCS         
Principal Investigator: Philip Rajan Devesahayam, MMed FRCS         
Sub-Investigator: Hong Bee Ker, MD MRCP         
Hospital Tuanku Fauziah Recruiting
Kangar, Perlis, Malaysia, 01000
Contact: Mohd Zambri Ibrahim, MD MMed         
Principal Investigator: Mohd Zambri Ibrahim, MD MMed         
Sub-Investigator: Suhaila Abd Wahab, MBBS MMed         
Hospital Queen Elizabeth Recruiting
Kota Kinabalu, Sabah, Malaysia, 88200
Contact: Halimuddin Sawali, MBBS MS         
Principal Investigator: Halimuddin Sawali, MBBS MS         
Sub-Investigator: Heng Gee Lee, MBChB MRCP         
Sarawak General Hospital Recruiting
Kuching, Sarawak, Malaysia, 93586
Contact: Chun Yiing Wong, MBBS MMed         
Principal Investigator: Chun Yiing Wong, MBBS MMed         
Sub-Investigator: Hock Hin Chua, MD MRCP         
Hospital Sungai Buloh Recruiting
Sungai Buloh, Selangor, Malaysia, 47000
Contact: Sobani Din, MD MS         
Principal Investigator: Sobani Din, MD MS         
Sub-Investigator: Carren Sui Lin Teh, MD MS         
Sub-Investigator: Kuldip Kaur Prem Kaur, MBBS MPH         
Sub-Investigator: Nor Arisah Misnan, MBBS MMed         
Hospital Sultanah Nur Zahirah Recruiting
Kuala Terengganu, Terengganu, Malaysia, 20400
Contact: Amran Mohamad, MD MS         
Principal Investigator: Amran Mohamad, MD MS         
Sub-Investigator: Mohd Noor Ismail, MD MRCP         
Kuala Lumpur General Hospital Recruiting
Kuala Lumpur, Malaysia, 50586
Contact: Elang Kumaran Krishnan, MBBS MS         
Principal Investigator: Elang Kumaran Krishnan, MBBS MS         
Sub-Investigator: Chee Loon Leong, MBBS MMed         
Hospital Melaka Recruiting
Melaka, Malaysia, 75400
Contact: Linda Pei Fang Lim, MD MS         
Principal Investigator: Linda Pei Fang Lim, MD MS         
Sub-Investigator: Nor Zaila Zaidan, MD MMed         
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
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Study Chair: Siti Sabzah Mohd Hashim, MD MS Hospital Sultanah Bahiyah
Additional Information:
Publications:

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Responsible Party: Siti Sabzah bt Mohd Hashim, MD, MS (ORL-HNS), Head of Otorhinolaryngology Service, Ministry of Health, Malaysia & Senior Consultant Otorhinolaryngologist, Hospital Sultanah Bahiyah
ClinicalTrials.gov Identifier: NCT04384042    
Other Study ID Numbers: MCO-002
NMRR-20-934-54803 ( Other Identifier: National Medical Research Register (NMRR), Malaysia )
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siti Sabzah bt Mohd Hashim, MD, MS (ORL-HNS), Hospital Sultanah Bahiyah:
Cross-sectional study
Prevalence
Otorhinolaryngology
Infectious Diseases
Anosmia
Dysgeusia
Olfactory Disorders
Taste Disorders
COVID-19
SARS-CoV-2
Coronavirus 2019
Additional relevant MeSH terms:
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Infections
COVID-19
Severe Acute Respiratory Syndrome
Anosmia
Dysgeusia
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Taste Disorders