Clinical trial NCT04384042: Malaysian COVID-19 Anosmia Study (Phase 2) - A Nationwide Multicentre Case-Control 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
COVID-19
Anosmia
Dysgeusia
Keywords: Cross-sectional study
Prevalence
Otorhinolaryngology
Infectious Diseases
Anosmia
Dysgeusia
Olfactory Disorders
Taste Disorders
COVID-19
SARS-CoV-2
Coronavirus 2019
Lead sponsor: Hospital Sultanah Bahiyah
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Tuanku Fauziah, Kangar, Perlis
name: Penang Hospital, Malaysia
name: Hospital Raja Permaisuri Bainun
name: Hospital Sungai Buloh, Selangor
name: Kuala Lumpur General Hospital
name: Hospital Tuanku Jaafar, Seremban, Negeri Sembilan
name: Hospital Melaka, Melaka
name: Hospital Enche Besar Hajjah Khalsom, Kluang, Johor
name: Hospital Raja Perempuan Zainab II, Kota Bahru, Kelantan
name: Hospital Sultanah Nur Zahirah, Kuala Terengganu
name: Hospital Tengku Ampuan Afzan, Kuantan, Pahang
name: Sarawak General Hospital
name: Hospital Queen Elizabeth, Malaysia
First posted: 2020-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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).

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.

Eligibility 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

Primary outcomes:
measure: Presence or absence of olfactory and taste disturbances in study participants
timeFrame: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
measure: Adjusted odds ratio of olfactory & taste disturbances in COVID-19 infection
timeFrame: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
Secondary outcomes:
measure: Clinical manifestations of study participants
timeFrame: 2 weeks prior to answering questionnaire/ prior to diagnosis of COVID-19 infection
measure: Other pre-existing health conditions
timeFrame: Baseline
measure: Positive predictive value (PPV) of olfactory and taste disturbances in predicting diagnosis of COVID-19 infection
timeFrame: Baseline
measure: Negative predictive value (NPV) of olfactory and taste disturbances in predicting absence of COVID-19 infection
timeFrame: Baseline
measure: Sensitivity of olfactory and taste disturbances in predicting COVID-19 infection
timeFrame: Baseline
measure: Specificity of olfactory and taste disturbances in predicting COVID-19 infection
timeFrame: Baseline
Other outcomes:
Locations:
city: Kluang
country: Malaysia
facility: Hospital Enche' Besar Hajjah Khalsom
state: Johor
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
state: Negeri Sembilan
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: George Town
country: Malaysia
facility: Penang Hospital
state: Penang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kangar
country: Malaysia
facility: Hospital Tuanku Fauziah
state: Perlis
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
state: Sabah
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
state: Selangor
city: Kuala Terengganu
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Kuala Lumpur General Hospital
city: Melaka
country: Malaysia
facility: Hospital Melaka
Study officials:
affiliation: Hospital Sultanah Bahiyah
name: Siti Sabzah Mohd Hashim, MD MS
role: STUDY_CHAIR
References:
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