UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042191 |
|---|---|
| Receipt number | R000048159 |
| Scientific Title | Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2020/10/21 15:43:46 |
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Basic information
Public title
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
Acronym
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19?
Scientific Title
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
Scientific Title:Acronym
Does going to the Orthopaedic outpatient clinic in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Subjects were patients who went to the Orthopaedic outpatient clinic of our institution from April to May 2020. Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who had fever were excluded from the study.
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the association between going to the Orthopaedic outpatient clinic and the risk of developing COVID-19.
Basic objectives2
Others
Basic objectives -Others
Prognosis, Risk Ratio
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variables analysed in this study includes age, gender, marital status, clinical symptoms, smoking status, comorbidities, any history of visitation to pandemic countries, and any frequent contact with COVID-19-positive patients. These variables are considered risk factors that may contribute to the development of COVID-19 infection.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | months-old | <= |
Age-upper limit
| 74 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects were patients who went to the Orthopaedic outpatient clinic of our institution from April to May 2020.
Key exclusion criteria
Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who had fever were excluded from the study
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Achmad |
| Middle name | Fauzi |
| Last name | Kamal |
Organization
Department of Orthopaedics and Traumatology, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Division name
Musculoskeletal Oncology and Reconstructive Division
Zip code
10430
Address
Jl. Diponegoro no. 71, Jakarta 10430 Indonesia
TEL
+6281511450189
fauzikamal@yahoo.com
Public contact
Name of contact person
| 1st name | I Wayan Arya Mahendra |
| Middle name | |
| Last name | Karda |
Organization
Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Division name
Department of Orthopaedics and Traumatology
Zip code
10430
Address
Jl. Diponegoro no. 71, Jakarta 10430 Indonesia
TEL
6287788408163
Homepage URL
arya961mahendra@gmail.com
Sponsor or person
Institute
Universitas Indonesia
Institute
Department
Personal name
Funding Source
Organization
Universitas Indonesia
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
Address
Gedung Fakultas Kedokteran UI JI. Salemba Raya No.6, Jakarta 10430 PO.Box 1358
Tel
+62213912477
humas@fk.ui.ac.id
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
54
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a combined retrospective and prospective study and performed at the Orthopaedic outpatient clinic at a national tertiary hospital in Jakarta, Indonesia. Variables analysed including age, gender, marital status, clinical symptoms, smoking status, comorbidities, and any history of visitation to pandemic countries and any frequent contact with COVID-19-positive patients. Physical examination, laboratory testing and plain x-ray of the thorax were done to evaluate the outcome.
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048159
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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