UMIN-CTR Clinical Trial

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
Email	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
Email	arya961mahendra@gmail.com

Sponsor
Institute	Universitas Indonesia
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048159