UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043403 |
|---|---|
| Receipt number | R000049453 |
| Scientific Title | Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2022/02/24 10:20:30 |
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Basic information
Public title
Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Acronym
Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Scientific Title
Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Scientific Title:Acronym
Identifying the risk of COVID-19 between different underlying comorbidities through the collaborative effort of Core Hospitals for Clinical Research in Japan
Region
| Japan |
Condition
Condition
All patients who visited the participating hospitals between March 1st, 2020 and December 3st, 2020, and who meets the inclusion criteria, and not meet the exclusion criteria are included in the current study
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients who visited the participating Core Hospitals for Clinical Research will be evaluated for their risk of onset of COVID-19 and their comorbidities
Basic objectives2
Others
Basic objectives -Others
We will evaluate the feasibility of the collaborative network project among Core Hospitals for Clinical Research in gathering Real World Data and establishing Real World Evidence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of COVID-19
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the participating institute more than twice between March 1st, 2020 and December 31st, 2020. For the patients who were positive for COVID-19, they would be enrolled in the study even with a one time visit.
Key exclusion criteria
1) Patients who declared to opt out of the study
2) patients whose data cannot be used for this study according to the participating institutes' previously defined policy (for example the patient is currently enrolled in a different clinical trial)
Target sample size
7000000
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Saya |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
hsaya@a6.keio.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Takemura |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
rtakemura@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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 | 02 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective Cohort study to assess the risk of COVID-19 infection according to underlying comorbidities. The outcome is defined as COVID-19 infection, defined by ICD10 code of U07.1 2019-nCoV acute respiratory disease. We will also collect information of the patients' underlying comorbidities from their diagnosis, as well as data on prescription, lab result, age and admission/discharge information.
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049453
| 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 |
