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

Last updated: February 23, 2021
Sponsor: Hospital Sultanah Bahiyah
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04384042
MCO-002
NMRR-20-934-54803
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age at least 18 years old
  2. For Cases: Laboratory confirmed COVID-19 infection [Reverse Transcription PolymeraseChain Reaction (RT-PCR)]
  3. Patients clinically able to answer the questionnaire

Exclusion

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

Study Design

Total Participants: 60
Study Start date:
June 06, 2020
Estimated Completion Date:
March 31, 2021

Study 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.

Connect with a study center

  • Hospital Sultanah Aminah

    Johor Bahru, Johor 80100
    Malaysia

    Site Not Available

  • Hospital Enche' Besar Hajjah Khalsom

    Kluang, Johor 86000
    Malaysia

    Active - Recruiting

  • Hospital Sultanah Bahiyah

    Alor Setar, Kedah 05400
    Malaysia

    Active - Recruiting

  • Hospital Sultanah Maliha

    Langkawi, Kedah 07000
    Malaysia

    Site Not Available

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan 15200
    Malaysia

    Active - Recruiting

  • Hospital Tuanku Jaafar

    Seremban, Negeri Sembilan 70300
    Malaysia

    Active - Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang 25100
    Malaysia

    Active - Recruiting

  • Penang Hospital

    George Town, Penang 10990
    Malaysia

    Active - Recruiting

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak 30450
    Malaysia

    Active - Recruiting

  • Hospital Tuanku Fauziah

    Kangar, Perlis 01000
    Malaysia

    Active - Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah 88200
    Malaysia

    Active - Recruiting

  • Sarawak General Hospital

    Kuching, Sarawak 93586
    Malaysia

    Active - Recruiting

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor 47000
    Malaysia

    Active - Recruiting

  • Hospital Sultanah Nur Zahirah

    Kuala Terengganu, Terengganu 20400
    Malaysia

    Active - Recruiting

  • Kuala Lumpur General Hospital

    Kuala Lumpur, 50586
    Malaysia

    Active - Recruiting

  • Hospital Melaka

    Melaka, 75400
    Malaysia

    Active - Recruiting

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