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Heart-Saving combo: steroid plus standard therapy may shield kids from kawasaki damage

NCT ID NCT04078568

Disease control Sponsor: Children's Hospital of Fudan University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a steroid called prednisolone to the usual treatment (immunoglobulin and aspirin) could reduce heart artery damage in children with Kawasaki disease. Over 3,200 children took part. The goal was to see if the combination therapy lowers the chance of coronary artery lesions, which can lead to long-term heart problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,208 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Kawasaki disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kawasaki disease

Contacts and locations

Locations

  • Anhui Children's Hospital

    Hefei, Anhui, 230022, China

  • Bengbu First People's Hopital

    Bengbu, Anhui, 233000, China

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610074, China

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014, China

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210008, China

  • Children's Hospital, Capital Institute of Pediatrics

    Beijing, Beijing Municipality, 100020, China

  • Children's hospital of Soochow University

    Suzhou, Jiangsu, 215003, China

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510623, China

  • Hangzhou First people's Hospital

    Hangzhou, Zhejiang, 310006, China

  • Henan Children's Hospital

    Zhengzhou, Henan, 450018, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410002, China

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017, China

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi, 330006, China

  • Kaifeng Children's Hospital

    Kaifeng, Henan, 475000, China

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030, China

  • Liuzhou Maternity and Children Healthcare Hospital

    Liuzhou, Guangxi, 545001, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Qingdao Women and Children's Hospital

    Qingdao, Shandong, 266011, China

  • Qingdao Women and Children's Hospital (Liaoyang West Road)

    Qingdao, Shandong, 266011, China

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, 200040, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518038, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120, China

  • Taihe Hospital Affiliated Hospital of Hubei University of Medicine

    Shiyan, Hubei, 442000, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

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

    Wuhan, Hubei, 430022, China

  • Xi'an Children's Hospital

    Xi'an, Shaanxi, 710003, China

  • Xiamen Children's Hospital

    Xiamen, Fujian, 361006, China

  • Xuzhou Children's Hospital

    Xuzhou, Jiangsu, 221006, China

  • Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325027, China

  • the First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.