UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040838 |
|---|---|
| Receipt number | 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 | 2024/03/31 23:43:16 |
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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
kenjiw1779@gmail.com
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
kenjiw1779@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine, Center for Inflammatory Bowel Disease, Division of Internal Medicine
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
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
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046628
