UMIN-CTR Clinical Trial

Basic information
Public title	Reserch on patients with COVID-19 at Osaka Saiseikai Nakatsu Hospital
Acronym	Reserch on COVID-19 at Saiseikai Nakatsu Hospital
Scientific Title	Epidemioligical reserch on patients with COVID-19 at Osaka Saiseikai Nakatsu Hospital
Scientific Title:Acronym	Epidemioligical reserch on COVID-19 at Osaka
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Medicine in general Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To characterize infected patients without a history of direct coronavirus exposure
Basic objectives2	Others
Basic objectives -Others	Epidemiological Survey
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Describe the distribution of coronavirus at Saiseikai Nakatsu Hospital
Key secondary outcomes	Characterization of patients who underwent PCR testing Characterization of infected patients without a history of direct coronavirus exposure Characterization of infected patients without findings of pneumonia Differences between patients with and those without a history of exposure Risk factors of patients with hypoxia Risk factors of patients with poor treatment response

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with medical chart data about coronavirus at Saiseikai Nakatsu Hospital
Key exclusion criteria	Patients who refused participation in this study
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Ueda
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Respiratory Medicine
Zip code	530-0012
Address	10-39 Shibata 2-chome, Kita-ku, Osaka 530-0012, Japan
TEL	06-6372-0333
Email	t-ueda@nakatsu.saiseikai.or.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Ueda
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Respiratory Medicine
Zip code	530-0012
Address	10-39 Shibata 2-chome, Kita-ku, Osaka 530-0012, Japan
TEL	06-6372-0333
Homepage URL
Email	t-ueda@nakatsu.saiseikai.or.jp

Sponsor
Institute	Osaka Saiseikai Nakatsu Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Osaka Saiseikai Nakatsu Hospital
Address	2-10-39 Shibata, Kita-ku, Osaka, Osaka
Tel	06-6372-0333
Email	d_torii@nakatsu.saiseikai.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2020-7
Org. issuing International ID_1	The Ethical Committee of Saiseikai Nakatsu Hosspital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	済生会中津病院（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 14 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
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	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 12 Day
Date of IRB	2020 Year 06 Month 03 Day
Anticipated trial start date	2020 Year 02 Month 13 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	An observational study

Management information
Registered date	2020 Year 07 Month 14 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045985