Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

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Brief Title

Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

Official Title

Efficacy of Primary Treatment With Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease: a Multicenter, Open-label, Blinded-end Randomized Controlled Study.

Brief Summary

      This study evaluates the efficacy of the addition of infliximab to conventional initial
      treatment (intravenous immunoglobulin [IVIG] plus aspirin) in early regression of coronary
      artery lesion in patients with Kawasaki disease (KD).
    

Detailed Description

      This is a multicenter, open-label, blind-end, randomized controlled trial at 5 hospitals in
      Shanghai, China. The KD children diagnosed within 14 days of onset according to the
      diagnostic criteria for KD released by American Heart Association (AHA) in 2017 will be
      considered for participants in the trial. The patients meeting eligibility criteria will be
      randomly assigned in a 1:1 ratio to the control group (receiving 2 g/kg*1 IVIG and 30 mg/kg/d
      aspirin) or intervention group (receiving 2 g/kg*1 IVIG, 30 mg/kg/d aspirin and additional 5
      mg/kg*1 infliximab) based on the randomly block design (block sizes 4). Baseline
      characteristics of each participant will be collected, including sex, age of onset, height,
      body weight, subtype of KD, fever days before initial IVIG, other clinical manifestations,
      echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests.
      Two-dimensional echocardiography will be performed at least 7 timepoints: at admission, 2
      weeks, 1 month, 3 months, 6 months, 9 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 the regression of coronary artery lesion (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 2 g/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 72 hours 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

0

Start Date

October 2020

Completion Date

September 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Meeting diagnostic criteria for KD released by American Heart Association (AHA) in
             2017, including complete KD (also sometimes referred to as typical or classic KD) and
             incomplete KD ((also sometimes referred to as atypical KD);

          -  Diagnosed within 14 days of illness (including the 14th day, considering the first day
             of illness as the first day of fever);

          -  Not treated with IVIG or other treatments for KD yet;

          -  Z score of any coronary artery of LMCA, LAD, LCX, the proximal and middle segment of
             RCA ≥ 2 calculated based on the height, weight and coronary artery diameter measured
             by echocardiography;

          -  Aged between one month and 14 years.

        Exclusion Criteria:

          -  Receiving steroids or other immunosuppressive agents in the previous 30 days;

          -  With a previous history of KD;

          -  Afebrile and all the inflammation indicators (including white blood cell count, CRP,
             and erythrocyte sedimentation) become normal before enrolment;

          -  With suspected infectious diseases including tuberculosis, sepsis, septic meningitis,
             peritonitis, bacterial pneumonia, varicella, influenza, EBV infection, etc;

          -  With serious immune diseases such as immunodeficiency or chromosomal abnormalities;

          -  Unable to be followed up for at least 1 year.
      

Gender

All

Ages

1 Month - 14 Years

Accepts Healthy Volunteers

No

Contacts

Guoying Huang, MD., , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04535518

Organization ID

KD-4-01


Responsible Party

Sponsor

Study Sponsor

Children's Hospital of Fudan University

Collaborators

 Shanghai Children's Hospital

Study Sponsor

Guoying Huang, MD., Study Director, Children's Hospital of Fudan University


Verification Date

March 2021