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

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) .

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, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, 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.

Sponsors & Collaborators

• Jiangxi Province Children's Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Inner Mongolia People's Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

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

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Children's Hospital of Soochow University

  collaborator OTHER

• Yuying Children's Hospital of Wenzhou Medical University

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• Fang Liu, MD. · Children's Hospital of Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-15

Primary Completion

2024-12-30

Completion

2025-11-06

Countries

• China

Study Locations