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Completed

NCT Number: NCT04898231

MIS-C Comparative Effectiveness Study

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.

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Key information

Conditions

Multisystem Inflammatory Syndrome-Children

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rady Children's Hospital, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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):

Cardiac

  • Hypotension
  • Shock
  • Arrhythmia
  • Tachycardia
  • Left ventricular ejection fraction <55%
  • Valvulitis
  • Coronary artery enlargement (LAD or RCA Z-score ≥ 2.5)
  • Pericardial effusion Gastrointestinal
  • Diarrhea
  • Nausea/vomiting
  • Significant abdominal pain Immunologic
  • Lymphadenopathy (unilateral cervical or diffuse) Mucocutaneous
  • Bilateral conjunctival injection
  • Extremity swelling or erythema
  • Rash
  • Lip erythema/Strawberry tongue Neurologic
  • Altered mental status
  • Focal neurological deficits
  • Headache
  • 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.

Exclusion criteria

  • Known immunodeficiency
  • Pre-existing medical condition that precludes receiving one or more of the study medications (e.g. TB, drug allergy to study medication).

Treatment and study plan

Infliximab

Drug

Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.

Other names: Remicade, Inflectra, Remsima

Anakinra

Drug

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.

Other names: Kineret

methylprednisolone

Drug

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.

Other names: Steriods

Primary outcomes

  1. Number of Participants Needing Additional Anti-inflammatory Therapy Within the First Week of First Randomization

    Time frame: 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.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 6 weeks

    Of the three initial randomization arms (infliximab, steroids or anakinra), the rate of adverse events will be compared. The goal is to determine which arm has the lowest rate of adverse events. The AEs reported in the AE section include: All Cause, SAE and Others.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Children's Hospital of Michigan

Registry information

Official study title

Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study

Acronym: MISTIC

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 24, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.