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

  • End date
    Dec 28, 2023
  • participants needed
  • sponsor
    Children's Hospital of Fudan University
Updated on 28 August 2023
immune globulin


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) .


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.

Condition Kawasaki Disease
Treatment Aspirin, Prednisolone, IVIG
Clinical Study IdentifierNCT04078568
SponsorChildren's Hospital of Fudan University
Last Modified on28 August 2023


Yes No Not Sure

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
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