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SARS-CoV InfectionNCT04384042

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

An observational study of SARS-CoV Infection and COVID-19, run by Hospital Sultanah Bahiyah at 14 sites in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV Infection, COVID-19, Anosmia
What is being tested?
Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
How many people
60 participants
Where
14 sitesMalaysia
Study dates
6 Jun 2020to 31 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

Siti Sabzah Mohd Hashim, MD MS contact

+604 740 7335

dr_ctsabzah@yahoo.com

Shen-Han Lee, MB PhD MRCS contact

+6016 474 0088

shen-han.lee@cantab.net

14 sites in 1 country

Malaysia14 sites, 14 recruiting

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05400

    Siti Sabzah Mohd Hashim, MD MS

    Shen-Han Lee, MB PhD MRCS

    Recruiting

  • Penang Hospital

    George Town, Pulau Pinang, 10990

    Chenthilnathan Periasamy, MBBS MMed

    Chenthilnathan Periasamy, MBBS MMed

    Recruiting

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450

    Philip Rajan Devesahayam, MMed FRCS

    Philip Rajan Devesahayam, MMed FRCS

    Recruiting

  • Hospital Tuanku Fauziah

    Kangar, Perlis, 01000

    Mohd Zambri Ibrahim, MD MMed

    Mohd Zambri Ibrahim, MD MMed

    Recruiting

  • Hospital Enche' Besar Hajjah Khalsom

    Kluang, Johor, 86000

    Jothi Shanmuganathan, MBBS MMed

    Jothi Shanmuganathan, MBBS MMed

    Recruiting

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15200

    Zulkiflee Salahuddin, MD MS

    Zulkiflee Salahuddin, MD MS

    Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah, 88200

    Halimuddin Sawali, MBBS MS

    Halimuddin Sawali, MBBS MS

    Recruiting

  • Kuala Lumpur General Hospital

    Kuala Lumpur, 50586

    Elang Kumaran Krishnan, MBBS MS

    Elang Kumaran Krishnan, MBBS MS

    Recruiting

  • Hospital Sultanah Nur Zahirah

    Kuala Terengganu, Terengganu, 20400

    Amran Mohamad, MD MS

    Amran Mohamad, MD MS

    Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

    Suhaimi Yusuf, MBBS MMed

    Suhaimi Yusof, MBBS MMed

    Recruiting

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

    Chun Yiing Wong, MBBS MMed

    Chun Yiing Wong, MBBS MMed

    Recruiting

  • Hospital Melaka

    Malacca, 75400

    Linda Pei Fang Lim, MD MS

    Linda Pei Fang Lim, MD MS

    Recruiting

  • Hospital Tuanku Jaafar

    Seremban, Negeri Sembilan, 70300

    Jeyasakthy Saniasiaya, MMed FEBORL

    Jeyasakthy Saniasiaya, MMed FEBORL

    Recruiting

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor, 47000

    Sobani Din, MD MS

    Sobani Din, MD MS

    Recruiting

Other trials in Malaysia

About this study

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

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).

Read the 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.

Being tested
Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
Keywords
Cross-sectional study, Prevalence, Otorhinolaryngology, Infectious Diseases, Anosmia, Dysgeusia, Olfactory Disorders, Taste Disorders, COVID-19, SARS-CoV-2, Coronavirus 2019
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19, Anosmia, Dysgeusia, Communicable Diseases, Taste Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient-Reported Online Questionnaire on Olfactory & Taste DisturbancesOther

    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.

Study groups in NCT04384042
Study groupRoleWhat they receive
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.
Receives: Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances
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.
Receives: Other: Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

    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.

    Measured: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

Secondary outcomes (6)

  1. Clinical manifestations of study participants

    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)

    Measured: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection

  2. Other pre-existing health conditions

    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.)

    Measured: Baseline

  3. Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection

    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%

    Measured: Baseline

  4. Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection

    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%

    Measured: Baseline

  5. Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection

    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%

    Measured: Baseline

  6. Specificity of olfactory and taste disturbances in predicting COVID-19 infection

    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%

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start6 Jun 2020
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion31 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384042
Sponsor's protocol ID
MCO-002
Other IDs
NMRR-20-934-54803
Status last verified
Feb 2021
First submitted
10 May 2020
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31986264

  • 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.

    PubMed 32215618

  • 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.

    PubMed 32275288

  • 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.

    PubMed 32253535

  • 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.

    PubMed 32340555

  • 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.

    PubMed 32279441

  • 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.

    PubMed 32320008

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV Infection and COVID-19, run by Hospital Sultanah Bahiyah at 14 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Siti Sabzah Mohd Hashim, MD MS (+604 740 7335, dr_ctsabzah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384042, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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