UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041579 |
|---|---|
| Receipt number | R000047464 |
| Scientific Title | A multicenter, retrospective longitudinal observational study about Quarantine and social Isolation for COVID-19 and its impact on Kawasaki disease |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2022/02/26 23:26:05 |
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Basic information
Public title
A multicenter, retrospective longitudinal observational study about Quarantine and social Isolation for COVID-19 and its impact on Kawasaki disease
Acronym
QUICK study
Scientific Title
A multicenter, retrospective longitudinal observational study about Quarantine and social Isolation for COVID-19 and its impact on Kawasaki disease
Scientific Title:Acronym
QUICK study
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the pathogens spread by contact or droplets would have an association with the occurrence of Kawasaki Disease.
Basic objectives2
Others
Basic objectives -Others
The change in clinical features and the presence of SARS-CoV-2 in KD patients in 2020.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of the number of patients with KD to patients with infections was admitted from February to May 2015-2019 and 2020.
Key secondary outcomes
Clinical features of Kawasaki Disease in 2020.
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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patient admitted from 2017 to 2020.
2) patient admitted with a diagnosis of KD or an infectious disease.
The diagnosis of KD was made based on Japanese diagnostic guidelines for Kawasaki disease. Both complete and incomplete KD are included. Include infectious diseases are as follows; respiratory tract infection (respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus, influenza virus, Streptococcus pyogenes, the others, and unknown pathogens), gastrointestinal infection, exanthema subitum, skin and soft tissue infection. In patients with respiratory tract infections, pathogens are identified with serological tests, culture, or rapid immunochromatographic tests.
Key exclusion criteria
1) admission for the recurrence of the same disease within 4 weeks
2) patient with immunodeficiency
3) patient with rheumatic disease, autoimmune disease or malignant disease
4) patient receiving immunosuppressive agents
5) patient who moved from other medical areas within 2 weeks before admission.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Hara |
Organization
Fukuoka Children's Hospital
Division name
Kawasaki disease center
Zip code
8130017
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
TEL
+81-92-682-7000
hara.t@fcho.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Furuno |
Organization
Fukuoka Children's Hospital
Division name
Kawasaki disease center
Zip code
8130017
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
TEL
+81-92-682-7000
Homepage URL
furuno.k@kd-research.com
Sponsor or person
Institute
Fukuoka Children's Hospital
Kawasaki disease center
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Children's Hospital Research Grant
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Children's Hospital
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
Tel
+81-92-682-7000
okada.sy@fcho.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
九州大学病院（福岡県）、国立病院機構九州医療センター（福岡県）、福岡赤十字病院（福岡県）、国家公務員共済組合浜の町病院（福岡県）、国立病院機構福岡東医療センター（福岡県）、自治医科大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
http://www.fcho.jp/childhp/security.html
Publication of results
Published
Result
URL related to results and publications
JAMA Netw Open. 2021;4(4):e214475. Published 2021 Apr 1. doi:10.1001/jamanetworkopen.2021.4475
Number of participants that the trial has enrolled
1649
Results
Admissions for KD showed no significant change between April and May in 2015 to 2019 vs the same months in 2020. However, the number of admissions for droplet-transmitted or contact-transmitted respiratory tract infections decrease; and gastrointestinal infections showed significant decreases between April and May in 2015 to 2019 vs the same months in 2020.
Results date posted
| 2022 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
This multicenter, longitudinal, cross-sectional study was conducted from 2015 to 2020 at Fukuoka Children's Hospital and 5 adjacent general hospitals.
Participant flow
The number of admissions for KD and infectious diseases were analyzed. Participants were pediatric patients admitted to the participating hospitals for KD or infectious diseases.
Adverse events
Not applicable
Outcome measures
The primary end points were the ratios of patients with KD to patients with respiratory tract or gastrointestinal infections admitted from April to May in 2015 to 2019 and 2020.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Demographic information in all patients included age, gender, and date of birth.
In patients with KD, clinical information including, days of illness on admission and at diagnosis, past history, clinical manifestations (duration of fever, and other symptoms), laboratory data, treatment, cardiac involvement and prognosis are reviewed. Laboratory data include white blood cell count (WBC), neutrophil percentage, hemoglobin, platelet count, total bilirubin, aspartate transaminase, alanine aminotransferase, serum sodium, and C-reactive protein. Treatment details include day of illness and dose of first intravenous immunoglobulin (IVIG) treatment, other intensification therapy, and needs of any additional therapy. Cardiac assessment has function, coronary diameter, valvular regurgitation, and pericardial effusion, which are evaluated at 3 time points: pretreatment, within 4weeks (the worst data), and after 4weeks. In KD patients in 2020, SARS-CoV-2 RNA or anti- SARS-CoV-2 IgG antibody results are corrected. IVIG resistance is defined when KD patients need additional IVIG therapy after 1st IVIG. Coronary arterial lesion (CAL) is defined when the Z-score of luminal diameter of one of the coronary arteries is > 2.5. In patients with infectious diseases, final diagnosis, diagnostic methods, and the pathogens are reviewed.
Management information
Registered date
| 2020 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047464
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