UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046536 |
|---|---|
| Receipt number | R000052556 |
| Scientific Title | Are common cold coronaviruses and novel coronaviruses inducers of Kawasaki disease? |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2024/01/15 19:12:20 |
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Basic information
Public title
Are common cold coronaviruses and novel coronaviruses inducers of Kawasaki disease?
Acronym
Are common cold coronaviruses and novel coronaviruses inducers of Kawasaki disease?
Scientific Title
Are common cold coronaviruses and novel coronaviruses inducers of Kawasaki disease?
Scientific Title:Acronym
Are common cold coronaviruses and novel coronaviruses inducers of Kawasaki disease?
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Testing the hypothesis that common cold coronaviruses and novel coronaviruses are inducers of Kawasaki disease
Basic objectives2
Others
Basic objectives -Others
Epidemiological studies
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of common cold coronavirus and novel coronavirus in patients with Kawasaki disease
Key secondary outcomes
Differences in the severity of Kawasaki disease according to affected viruses
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Kawasaki diseasse
Key exclusion criteria
Patients who have received immunoglobulin within the past 3 months
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Moriuchi |
| Middle name | |
| Last name | Hiroyuki |
Organization
Nagasaki University
Division name
Pediatrics
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7298
hiromori@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Otsuka |
| Middle name | |
| Last name | Masakazu |
Organization
Nagasaki University Hospital
Division name
Pediatrics
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7298
Homepage URL
m.otsuka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki University Institute of Tropical Medicine, JCHO Isahaya General Hospital, Nagasaki Minato Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City
Tel
095-819-7298
m.otsuka@nagasaki-u.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
長崎大学病院、長崎大学熱帯医学研究所
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 05 | 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
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Scheduled for two years from the date of Ethics Committee approval.
Management information
Registered date
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052556
