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

NCT04390165 | Completed

• 2 other identifiers: MCO-001NMRR-20-934-54803
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 14

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 cross-sectional study is described here (the case-control study is described in a separate ClinicalTrials.gov record).

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Clinical manifestations of study participants

  Within 2 weeks preceding the diagnosis of COVID-19 infection

• Other pre-existing health conditions

  Prior to diagnosis of COVID-19 infection

• Rating of baseline sense of smell & taste in COVID-19 patients prior to diagnosis of their infection

  Prior to 2 weeks preceding the diagnosis of COVID-19 infection (Baseline)

• Rating of sense of smell & taste in COVID-19 patients at time of diagnosis of their infection

  Within 2 weeks preceding the diagnosis of COVID-19 infection

• Rating of sense of smell & taste in COVID-19 patients at time of answering questionnaire survey

  Up to 6 months

Study Arms (1)

Malaysian COVID-19 Cohort

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

Interventions

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.

Malaysian COVID-19 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population are 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. These patients comprise those who either currently inpatient or already discharged into the community. For patients already discharged into the community, they will be invited to participate by phone call from the hospital treating team. Once verbal consent has been obtained, they a QR code or internet URL link to the online questionnaire website will be sent to these patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (14)

Hospital Enche' Besar Hajjah Khalsom

Kluang, Johor, 86000, Malaysia

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05400, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15200, Malaysia

Location

Hospital Tuanku Jaafar

Seremban, Negeri Sembilan, 70300, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

Location

Hospital Tuanku Fauziah

Kangar, Perlis, 01000, Malaysia

Location

Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, 88200, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Sungai Buloh

Sungai Buloh, Selangor, 47000, Malaysia

Location

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, 20400, Malaysia

Location

Kuala Lumpur General Hospital

Kuala Lumpur, 50586, Malaysia

Location

Hospital Melaka

Malacca, 75400, Malaysia

Location

Related Publications (8)

• 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.

  PMID: 31986264 BACKGROUND

• 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. No abstract available.

  PMID: 32215618 BACKGROUND

• 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.

  PMID: 32275288 BACKGROUND

• 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.

  PMID: 32253535 BACKGROUND

• 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.

  PMID: 32340555 BACKGROUND

• 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.

  PMID: 32279441 BACKGROUND

• 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.

  PMID: 32320008 BACKGROUND

• Lee SH, Yeoh ZX, Sachlin IS, Gazali N, Soelar SA, Foo CY, Low LL, Syed Alwi SB, Tengku Kamalden TMI, Shanmuganathan J, Zaid M, Wong CY, Chua HH, Yusuf S, Muhamad D, Devesahayam PR, Ker HB, Salahuddin Z, Mustafa M, Sawali H, Lee HG, Din S, Misnan NA, Mohamad A, Ismail MN, Periasamy C, Chow TS, Krishnan EK, Leong CL, Lim LPF, Zaidan NZ, Ibrahim MZ, Abd Wahab S, Mohd Hashim SS; Malaysian COVID-19 Anosmia Research Group. Self-reported symptom study of COVID-19 chemosensory dysfunction in Malaysia. Sci Rep. 2022 Feb 8;12(1):2111. doi: 10.1038/s41598-022-06029-6.

  PMID: 35136124 DERIVED

Related Links

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

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Anosmia; Dysgeusia; Communicable Diseases; Taste Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Siti Sabzah Mohd Hashim, MD MS

  Hospital Sultanah Bahiyah

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Otorhinolaryngology Service, Ministry of Health, Malaysia & Senior Consultant Otorhinolaryngologist

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 15, 2020
• Study Start: June 6, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (14)