Clinical trial NCT04078568: Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
Official title: Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Kawasaki Disease
Keywords: Kawasaki disease
prednisolone
coronary artery lesion
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Jiangxi Province Children's Hospital
name: First People's Hospital of Hangzhou
name: Shengjing Hospital
name: The First Hospital of Jilin University
name: Chengdu Women's and Children's Central Hospital
name: Children's Hospital of Chongqing Medical University
name: Inner Mongolia People's Hospital
name: Sichuan Provincial People's Hospital
name: Wuhan Union Hospital, China
name: Third Affiliated Hospital of Zhengzhou University
name: Children's Hospital of Soochow University
name: Yuying Children's Hospital of Wenzhou Medical University
name: Beijing Children's Hospital
name: Qilu Hospital of Shandong University
First posted: 2019-09-06
Enrollment: 3208
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

Detailed description: This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of KD to assess the coronary artery lesions.

Eligibility criteria: Inclusion Criteria:

* Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
* Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
* Not treated with IVIG yet
* Age ≥1 month

Exclusion Criteria:

* Z score of any coronary artery before initial treatment ≥10
* Receiving steroids or other immunosuppressive agents in the previous 30 days
* With a previous history of KD
* Afebrile before enrolment
* With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities

Primary outcomes:
measure: Percentage of coronary artery lesions(CAL) at one month of illness
timeFrame: at one month of illness
Secondary outcomes:
measure: Percentage of the need for additional treatment
timeFrame: from admission to discharge (about 2 weeks of illness)
measure: Duration of fever (hours) after initiation of initial IVIG infusion
timeFrame: from initiation of initial IVIG infusion to the first record of being afebrile(defined as an axillary temperature <37.5 for more than 24 hours)
measure: Changes in z scores of LMCA throughout the study period
timeFrame: from admission to 12 months of illness
measure: Changes in z scores of LAD throughout the study period
timeFrame: from admission to 12 months of illness
measure: Changes in z scores of LCX throughout the study period
timeFrame: from admission to 12 months of illness
measure: Changes in z scores of the proximal segment of RCA throughout the study period
timeFrame: from admission to 12 months of illness
measure: Changes in z scores of the middle segment of RCA throughout the study period
timeFrame: from admission to 12 months of illness
measure: Change in serum C-reactive protein (CRP) concentration
timeFrame: from admission to 72 hours after completion of initial IVIG infusion
measure: Number of patients with serious adverse events
timeFrame: from admission to 3 months of illness
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Bengbu First People's Hopital
state: Anhui
city: Hefei
country: China
facility: Anhui Children's Hospital
state: Anhui
city: Beijing
country: China
facility: Children's Hospital, Capital Institute of Pediatrics
state: Beijing
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Children's Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Maternity and Children Healthcare Hospital
state: Guangxi
city: Kaifeng
country: China
facility: Kaifeng Children's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital Affiliated Hospital of Hubei University of Medicine
state: Hubei
city: Wuhan
country: China
facility: Union Hospital,Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Inner Mongolia
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Children's hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Children's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Children's Hospital
state: Jiangxi
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Qingdao Women and Children's Hospital (Liaoyang West Road)
state: Shandong
city: Qingdao
country: China
facility: Qingdao Women and Children's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Children's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First people's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Children's Hospital of Fudan University
name: Fang Liu, MD.
role: STUDY_DIRECTOR
References:
citation: Lin SY, He L, Xie LP, Wang Y, Lin YX, Cao YY, Yan WL, Liu F, Huang GY. Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial. Trials. 2021 Dec 11;22(1):898. doi: 10.1186/s13063-021-05807-3.