Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384042
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 14, 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 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.

Layout table for study information
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
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 (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.


Layout table for eligibility information
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
Layout table for location contacts
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
Layout table for investigator information
Study Chair: Siti Sabzah Mohd Hashim, MD MS Hospital Sultanah Bahiyah
Additional Information:
Publications:

Layout table for additonal information
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
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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