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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046536
Receipt No. 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 2022/01/05

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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
Email 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
Email m.otsuka@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 05 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
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
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052556

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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