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
Verified date | February 2021 |
Source | Hospital Sultanah Bahiyah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
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 |
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 |
Malaysia,
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
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 |
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