Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

3,208

Participants

Timeline

Start Date

January 15, 2020

Primary Completion Date

December 30, 2024

Study Completion Date

December 31, 2025

Conditions
Kawasaki Disease
Interventions
DRUG

IVIG

IVIG at a single dose of 2 g/kg, with the maximum dose of 60g

DRUG

Aspirin

Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

DRUG

Prednisolone

Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days. If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

Trial Locations (34)

100020

Children's Hospital, Capital Institute of Pediatrics, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

130021

The First Hospital of Jilin University, Changchun

200040

Shanghai Children's Hospital, Shanghai

201102

Children's Hospital of Fudan University, Shanghai

210008

Children's Hospital of Nanjing Medical University, Nanjing

215003

Children's hospital of Soochow University, Suzhou

221006

Xuzhou Children's Hospital, Xuzhou

230022

Anhui Children's Hospital, Hefei

233000

Bengbu First People's Hopital, Bengbu

250012

Qilu Hospital of Shandong University, Jinan

266011

Qingdao Women and Children's Hospital (Liaoyang West Road), Qingdao

Qingdao Women and Children's Hospital, Qingdao

310006

Hangzhou First people's Hospital, Hangzhou

325027

Yuying Children's Hospital of Wenzhou Medical University, Wenzhou

330006

Jiangxi Provincial Children's Hospital, Nanchang

361006

Xiamen Children's Hospital, Xiamen

400014

Children's Hospital of Chongqing Medical University, Chongqing

410002

Hunan Provincial People's Hospital, Changsha

430022

Union Hospital,Tongji Medical College of Huazhong University of Science and Technology, Wuhan

442000

Taihe Hospital Affiliated Hospital of Hubei University of Medicine, Shiyan

450018

Henan Children's Hospital, Zhengzhou

450052

the First Affiliated Hospital of Zhengzhou University, Zhengzhou

The Third Affiliated Hospital of Zhengzhou University, Zhengzhou

475000

Kaifeng Children's Hospital, Kaifeng

510120

Sun Yat-sen Memorial Hospital, Guangzhou

510623

Guangzhou Women and Children's Medical Center, Guangzhou

518038

Shenzhen Children's Hospital, Shenzhen

545001

Liuzhou Maternity and Children Healthcare Hospital, Liuzhou

610072

Sichuan Provincial People's Hospital, Chengdu

610074

Chengdu Women's and Children's Central Hospital, Chengdu

710003

Xi'an Children's Hospital, Xi'an

730030

Lanzhou University Second Hospital, Lanzhou

010017

Inner Mongolia People's Hospital, Hohhot

All Listed Sponsors
collaborator

Jiangxi Province Children's Hospital

OTHER

collaborator

First People's Hospital of Hangzhou

OTHER

collaborator

Shengjing Hospital

OTHER

collaborator

The First Hospital of Jilin University

OTHER

collaborator

Chengdu Women's and Children's Central Hospital

OTHER

collaborator

Children's Hospital of Chongqing Medical University

OTHER

collaborator

Inner Mongolia People's Hospital

OTHER

collaborator

Sichuan Provincial People's Hospital

OTHER

collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

Third Affiliated Hospital of Zhengzhou University

OTHER

collaborator

Children's Hospital of Soochow University

OTHER

collaborator

Yuying Children's Hospital of Wenzhou Medical University

OTHER

collaborator

Beijing Children's Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

lead

Children's Hospital of Fudan University

OTHER