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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040838
Receipt No. R000046628
Scientific Title A seroprevalence study of COVID-19 in IBD patients
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/25

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Basic information
Public title A seroprevalence study of COVID-19 in IBD patients
Acronym A seroprevalence study of COVID-19 in IBD patients
Scientific Title A seroprevalence study of COVID-19 in IBD patients
Scientific Title:Acronym A seroprevalence study of COVID-19 in IBD patients
Region
Japan

Condition
Condition inflammatory bowel disease (IBD) patients in the broad sense
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relation between antibody formation of COVID-19 and the contents of immunomodulative therapy in patients with IBD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a positive rate of an anti-SARS-CoV-2 IgG antibody in serum of IBD patient
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 IBD patients
Interventions/Control_2 healthy control
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
14 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Broad IBD patients (ulcerative colitis, Crohn's disease, Behcet's disease, MEFV gene-related enterocolitis, SLCO2A1 gene-related enterocolitis, IBD unclassified)
Key exclusion criteria patients with active COVID-19
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Watanabe
Organization Hyogo College of Medicine
Division name Center for Inflammatory Bowel Disease, Division of Internal Medicine
Zip code 663-8501
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798456663
Email ke-watanabe@hyo-med.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Watanabe
Organization Hyogo College of Medicine
Division name Center for Inflammatory Bowel Disease, Division of Internal Medicine
Zip code 663-8501
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798456663
Homepage URL
Email ke-watanabe@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine, Center for Inflammatory Bowel Disease, Division of Internal Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine, Center for Inflammatory Bowel Disease, Division of Internal Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical committee of Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel 0798456066
Email rinri@hyo-med.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 大阪医科大学:第2内科、先端医療開発学寄附講座。大阪市立大学大学院医学研究科消化器内科学。正啓会 西下胃腸病院。

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 12 Day
Date of IRB
Anticipated trial start date
2020 Year 09 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

Management information
Registered date
2020 Year 06 Month 20 Day
Last modified on
2020 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046628

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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