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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390165
• Other study ID #: MCO-001
• Secondary ID: NMRR-20-934-5480
• Status: Completed
• Start date: June 6, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Hospital Sultanah Bahiyah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• Coronavirus Infections
• COVID-19
• Dysgeusia
• Infection
• Olfaction Disorders
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	Penang Hospital	George Town	Penang
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Tuanku Fauziah	Kangar	Perlis
Malaysia	Hospital Enche' Besar Hajjah Khalsom	Kluang	Johor
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu	Kelantan
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu	Sabah
Malaysia	Kuala Lumpur General Hospital	Kuala Lumpur
Malaysia	Hospital Sultanah Nur Zahirah	Kuala Terengganu	Terengganu
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Sarawak General Hospital	Kuching	Sarawak
Malaysia	Hospital Melaka	Melaka
Malaysia	Hospital Tuanku Jaafar	Seremban	Negeri Sembilan
Malaysia	Hospital Sungai Buloh	Sungai Buloh	Selangor

Sponsors (14)

Lead Sponsor

Collaborator

Hospital Sultanah Bahiyah

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, 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

Country where clinical trial is conducted

Malaysia, 

References & Publications (7)

Giacomelli A, Pezzati L, Conti F, Bernacchia D, Siano M, Oreni L, Rusconi S, Gervasoni C, Ridolfo AL, Rizzardini G, Antinori S, Galli M. Self-reported Olfactory and Taste Disorders in Patients With Severe Acute Respiratory Coronavirus 2 Infection: A Cross-sectional Study. Clin Infect Dis. 2020 Jul 28;71(15):889-890. doi: 10.1093/cid/ciaa330. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Kaye R, Chang CWD, Kazahaya K, Brereton J, Denneny JC 3rd. COVID-19 Anosmia Reporting Tool: Initial Findings. Otolaryngol Head Neck Surg. 2020 Jul;163(1):132-134. doi: 10.1177/0194599820922992. Epub 2020 Apr 28. Review. — View Citation

Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6. — View Citation

Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127. — View Citation

Spinato G, Fabbris C, Polesel J, Cazzador D, Borsetto D, Hopkins C, Boscolo-Rizzo P. Alterations in Smell or Taste in Mildly Symptomatic Outpatients With SARS-CoV-2 Infection. JAMA. 2020 May 26;323(20):2089-2090. doi: 10.1001/jama.2020.6771. — View Citation

Yan CH, Faraji F, Prajapati DP, Boone CE, DeConde AS. Association of chemosensory dysfunction and COVID-19 in patients presenting with influenza-like symptoms. Int Forum Allergy Rhinol. 2020 Jul;10(7):806-813. doi: 10.1002/alr.22579. Epub 2020 Jun 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of olfactory and taste disturbances in COVID-19 patients	In the patient-reported online questionnaire, subjects will be asked regarding whether they experienced symptoms of olfactory and/or taste disturbances	Within 2 weeks preceding the diagnosis of COVID-19 infection
Primary	Prevalence of olfactory disturbances in COVID-19 patients	Percentage of COVID-19 patients experiencing olfactory disturbances (anosmia or hyposmia)	Within 2 weeks preceding the diagnosis of COVID-19 infection
Primary	Prevalence of taste disturbances in COVID-19 patients	Percentage of COVID-19 patients experiencing taste disturbances	Within 2 weeks preceding the diagnosis of COVID-19 infection
Secondary	Clinical manifestations of study participants	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)	Within 2 weeks preceding the diagnosis of COVID-19 infection
Secondary	Other pre-existing health conditions	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.)	Prior to diagnosis of COVID-19 infection
Secondary	Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection	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	Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)
Secondary	Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their 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	Within 2 weeks preceding the diagnosis of COVID-19 infection
Secondary	Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey	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	Up to 6 months

External Links

•   AAO-HNS: Anosmia, Hyposmia, and Dysgeusia Symptoms of Coronavirus Disease | American Academy of Otolaryngology-Head and Neck Surgery