Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Number of Participants Needing Additional Anti-inflammatory Therapy Within the First Week of First Randomization
研究概览
简要总结
In March 2020, children exposed to the virus that causes the COVID-19 illness, SARS-CoV-2, presented with fever and significant inflammation about a month after exposure to the virus. Some children were sick enough to require care in the intensive care unit for what came to be known as Multisystem Inflammatory Syndrome-Children (MIS-C).The clinical presentation shared many features with Kawasaki disease (KD), a self-limited inflammation that can cause ballooning of the arteries of the heart. Thus, physicians reached for many of the therapies used to treat children with KD. Despite the surge of COVID-19 cases and children continuing to present with MIS-C, there are no data that guide the choice of therapy. Thus, the investigators have designed a study to determine which combination of therapies is most effective in helping children with MIS-C recover quickly.
详细描述
This study is a multi-site, randomized, pragmatic, comparative effectiveness study of children with MIS-C. The current standard of care is that all MIS-C patients are initially treated with IVIG and receive additional therapy if they are severely ill or do not improve clinically. This study design will randomize subjects who have received IVIG but clinically warrant further anti-inflammatory therapy to one of three treatment arms (infliximab, steroids or anakinra) and allow for re-randomization to one of the two remaining arms if clinically warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An individual aged <21 years presenting with
- •Fever (>38.0°C for ≥24 hours; may be by subjective report) AND
- •Two or more of the following (from two different systems; e.g. one from cardiac and one from mucocutaneous):
- •Hypotension
- •Arrhythmia
- •Tachycardia
- •Left ventricular ejection fraction <55%
- •Valvulitis
- •Coronary artery enlargement (LAD or RCA Z-score ≥ 2.5)
- •Pericardial effusion Gastrointestinal
- •Nausea/vomiting
- •Significant abdominal pain Immunologic
- •Lymphadenopathy (unilateral cervical or diffuse) Mucocutaneous
- •Bilateral conjunctival injection
- •Extremity swelling or erythema
- •Lip erythema/Strawberry tongue Neurologic
- •Altered mental status
- •Focal neurological deficits
- •Meningismus
- •Laboratory evidence of inflammation, including but not limited to, an elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, D-dimer, ferritin, lactic acid dehydrogenase (LDH), neutrophilia, lymphopenia or hypoalbuminemia AND
- •No alternative plausible diagnoses based on clinical judgement AND
- •Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or suspected COVID-19 exposure AND
- •Parent or legal guardian (or self if at least 18 years old) able and willing to provide informed consent and subject willing and able to provide assent when appropriate.
排除标准
- •Known immunodeficiency
- •Pre-existing medical condition that precludes receiving one or more of the study medications (e.g. TB, drug allergy to study medication).
研究组 & 干预措施
Infliximab
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
干预措施: Infliximab (Drug)
Methylprednisilone (steroids)
Methylprednisilone (steroids) will be administered as 2 mg/kg IV or orally divided every 12 hours. At the time of hospital discharge the patient will be given a steroid taper that will take at least 3 weeks to complete.
干预措施: Methylprednisolone (Drug)
Anakinra
Anakinra will be administered at a dose of 8 mg/kg/day IV or SQ with 100 mg every 6 hours as the max dose. This is discontinued with a taper during the hospitalization over 2-4 days once a patient is stable with significantly improved clinical course and laboratory profile.
干预措施: Anakinra (Drug)
结局指标
主要结局
Number of Participants Needing Additional Anti-inflammatory Therapy Within the First Week of First Randomization
时间窗: 1 week
The three arms of the study will be compared to see which initial randomization arm (infliximab, anakinra or steroids) has the lowest rate of additional anti-inflammatory therapy within the first week of first randomization.
次要结局
- Number of Participants With Adverse Events(6 weeks)
研究者
Adriana H. Tremoulet
Associate Director, Kawasaki Disease Research Center Professor of Pediatrics
University of California, San Diego