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

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Brief Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of coronary artery lesions(CAL) at one month of illness

Secondary Outcome

 Percentage of the need for additional treatment

Condition

Kawasaki Disease

Intervention

IVIG

Study Arms / Comparison Groups

 the standard group
Description:  IVIG 2g/kg once, given within 12 to 24 hours;
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3000

Start Date

January 15, 2020

Completion Date

December 2023

Primary Completion Date

December 2023

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
      

Gender

All

Ages

1 Month - N/A

Accepts Healthy Volunteers

No

Contacts

Fang Liu, MD., +86 021-64932800, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04078568

Organization ID

KD-3-01


Responsible Party

Sponsor

Study Sponsor

Children's Hospital of Fudan University

Collaborators

 Jiangxi Province Children's Hospital

Study Sponsor

Fang Liu, MD., Study Director, Children's Hospital of Fudan University


Verification Date

January 2022