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NCT Number: NCT04390165

Malaysian COVID-19 Anosmia Study (Phase 1) - A Nationwide Multicentre Cross-Sectional 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 cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).

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Key information

Conditions

SARS-CoV Infection Anosmia COVID-19 Communicable Diseases Coronaviridae Infections Coronavirus Infections Disease Attributes Dysgeusia Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Severe Acute Respiratory Syndrome Signs and Symptoms Taste Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Enche' Besar Hajjah Khalsom, Kluang, Johor, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age at least 18 years old
  • Laboratory confirmed COVID-19 infection [Reverse Transcription Polymerase Chain Reaction (RT-PCR)]
  • Patients clinically able to answer the questionnaire

Exclusion criteria

  • Patients with olfactory or taste/gustatory disorders before the COVID-19 epidemic
  • Patients without a laboratory-confirmed COVID-19 diagnosis
  • Patients in intensive care unit at the time of study

Treatment and study plan

Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Sultanah Bahiyah

Other Gov

Collaborators

  • Hospital Enche Besar Hajjah Khalsom, Kluang, Johor
  • Hospital Melaka, Melaka
  • Hospital Queen Elizabeth, Malaysia
  • Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan
  • Hospital Raja Permaisuri Bainun
  • Hospital Sultanah Nur Zahirah, Kuala Terengganu
  • Hospital Sungai Buloh, Selangor
  • Hospital Tengku Ampuan Afzan, Kuantan, Pahang
  • Hospital Tuanku Fauziah, Kangar, Perlis
  • Hospital Tuanku Jaafar, Seremban, Negeri Sembilan
  • Kuala Lumpur General Hospital
  • Penang Hospital, Malaysia
  • Sarawak General Hospital

Registry information

Official study title

Olfactory and Gustatory Disturbances as a Clinical Presentation of Coronavirus Disease 2019 (COVID-19) Infection in Malaysia - A Nationwide Multicentre Cross-Sectional Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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