Phase 3 Trial to Evaluate IVIG, Aspirin, Prednisolone Combination Therapy in Patients With Kawasaki Disease


Trial seeks to provide high-level evidence for improving the initial treatment for acute Kawasaki disease.

Investigators are currently recruiting for the first multicenter randomized controlled trial to evaluate the efficacy of the combination therapy intravenous immunoglobulin (IVIG) plus aspirin plus prednisolone in Chinese pediatric patients with Kawasaki disease (KD), according to an article published in Trials. The study is designed to provide high-level evidence for improving the initial treatment for acute KD.

According to the investigators, corticosteroids are controversial in the treatment of KD. Early meta-analysis indicated that the use of corticosteroids in aspirin-containing regimens for the primary treatment of KD could reduce the incidence of coronary aneurysms, which was maintained when IVIG was added to the treatment regimen.

A later randomized trial of the efficacy of the addition of a single pulsed dose of intravenous methylprednisolone to conventional IVIG therapy did not provide support for this conclusion. In response to this conflict in the evidence, as well as inconsistencies from later trials, the current study was designed.

This study is a multicenter, prospective, open label, randomized controlled trial, which is expected to be conducted in more than 20 hospitals in China, with the aim of assessing the efficacy and safety of IVIG plus prednisolone treatment compared to standard treatment. Recruitment began on January 13, 2020, and is expected to be completed in December 2021. Patients recruited will be randomized 1:1 to receive either IVIG and aspirin or IVIG, aspirin, and prednisolone.

The primary outcome of the prospective trial will be the occurrence of coronary artery lesions (CALs) at 1 month of illness, with a follow-up duration of 1 year for each participant. Patients and physicians will be unmasked to group allocation.

Secondary outcome measures include the need for rescue therapy, duration of fever from initiation of the initial IVIG infusion, changes in serum CRP concentration 72 hours after the completion of the initial IVIG infusion, and the frequency of adverse events (AEs).

Inclusion criteria for recruited patients include:

  1. Meeting the diagnostic criteria for KD published by the American Heart Association (AHA) in 2017, which include complete KD and incomplete KD.
  2. Being diagnosed within 10 days of onset.
  3. No prior treatment with IVIG.
  4. Age ≥ 1 month at the time of enrolment into the trial.

Recruitment will continue until a total of 3000 participants have been enrolled. Trial results will be published in a peer-reviewed scientific paper.


Lin SY, He L, Xie LP, et al. Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial. Trials 22, 898 (2021). doi:10.1186/s13063-021-05807-3

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