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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041102
Receipt No. R000045985
Scientific Title Epidemioligical reserch on patients with COVID-19 at Osaka Saiseikai Nakatsu Hospital
Date of disclosure of the study information 2020/07/14
Last modified on 2020/09/06

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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
2021 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
2020 Year 09 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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