UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041102 |
|---|---|
| Receipt number | 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 | 2021/11/25 20:08:55 |
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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
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
t-ueda@nakatsu.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045985
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
