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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040656
Receipt No. R000046390
Scientific Title Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19
Date of disclosure of the study information 2020/08/01
Last modified on 2020/06/04

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Basic information
Public title Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19
Acronym Japan COVID-19 surveillance in inflammatory bowel disease (J-COSMOS)
Scientific Title Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19
Scientific Title:Acronym Japan COVID-19 surveillance in inflammatory bowel disease (J-COSMOS)
Region
Japan

Condition
Condition inflammatory bowel disease
COVID-19
Classification by specialty
Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the rate of COVID-19 in Japanese IBD patients.
Basic objectives2 Others
Basic objectives -Others To invesigate the rate of Japanese IBD patients with COVID-19 and their clinical outcome.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The rate of Japanese IBD patients with COVID-19
Key secondary outcomes At the diagnosis of SARS-CoV-2 infection and COVID-19, treatment of IBD and the COVID-19 severity.

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 Inflammatory bowel disease patients with COVID-19 infection (ulcerative colitis, Crohn's disease, inflammatory bowel disease unclassified, intestinal Behcet's disease, simple ulcer)
Key exclusion criteria Those who refused to participate in the study by opr-out
Target sample size 200

Research contact person
Name of lead principal investigator
1st name HIROSHI
Middle name
Last name NAKASE
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 060-8543
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL 011-611-2111
Email hiropynakase@gmail.com

Public contact
Name of contact person
1st name DAISUKE
Middle name
Last name HIRAYAMA
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 060-8543
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL 011-611-2111
Homepage URL
Email hirarin95@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Sapporo Medical University Hospital
Address South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
Tel 011-611-2111
Email ji-rskk@sapmed.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 札幌医科大学(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 08 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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case registration will be made by the participating institutions.
At the moment, the deadline for patient registration is December 31, 2021.

Management information
Registered date
2020 Year 06 Month 04 Day
Last modified on
2020 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046390

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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