UMIN-CTR Clinical Trial

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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