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Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional Study

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ClinicalTrials.gov Identifier: NCT04390165
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
Hospital Tuanku Fauziah, Kangar, Perlis
Hospital Sultanah Maliha, Langkawi, Kedah
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 Sultan Ismail, Johor Bahru, Johor
Hospital Permai, Johor Bahru, Johor
Hospital Sultanah Aminah Johor Bahru
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 cross-sectional study is described here (the case-control 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-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.

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Study Type : Observational
Estimated Enrollment : 760 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Cross-Sectional Study
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020


Group/Cohort 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.




Primary Outcome Measures :
  1. Presence or absence of olfactory and taste disturbances in COVID-19 patients [ Time Frame: 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

  2. Prevalence of olfactory disturbances in COVID-19 patients [ Time Frame: Within 2 weeks preceding the diagnosis of COVID-19 infection ]
    Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)

  3. Prevalence of taste disturbances in COVID-19 patients [ Time Frame: Within 2 weeks preceding the diagnosis of COVID-19 infection ]
    Percentage of COVID-19 patients experiencing taste disturbances


Secondary Outcome Measures :
  1. Clinical manifestations of study participants [ Time Frame: 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)

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

  3. Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection [ Time Frame: 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

  4. Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection [ Time Frame: 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

  5. Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population are 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.

These patients comprise those who either currently inpatient or already discharged into the community. For patients already discharged into the community, they will be invited to participate by phone call from the hospital treating team. Once verbal consent has been obtained, they a QR code or internet URL link to the online questionnaire website will be sent to these patients.

Criteria

Inclusion Criteria:

  1. Age at least 18 years old
  2. 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. Patients without a laboratory-confirmed COVID-19 diagnosis
  3. 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): NCT04390165


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
Show Show 18 study locations
Sponsors and Collaborators
Hospital Sultanah Bahiyah
Hospital Tuanku Fauziah, Kangar, Perlis
Hospital Sultanah Maliha, Langkawi, Kedah
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 Sultan Ismail, Johor Bahru, Johor
Hospital Permai, Johor Bahru, Johor
Hospital Sultanah Aminah Johor Bahru
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: NCT04390165    
Other Study ID Numbers: MCO-001
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
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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Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Olfaction Disorders
Dysgeusia
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Taste Disorders