MIS-C Comparative Effectiveness Study

NCT04898231 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 202109
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multisystem Inflammatory Syndrome-Children

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 week

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  6 weeks

Study Arms (3)

Infliximab

ACTIVE COMPARATOR

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

Drug: Infliximab

Methylprednisilone (steroids)

ACTIVE COMPARATOR

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.

Drug: Methylprednisolone

Anakinra

ACTIVE COMPARATOR

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.

Drug: Anakinra

Interventions

Infliximab DRUG

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

Also known as: Remicade, Inflectra, Remsima

Infliximab

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.

Also known as: Kineret

Anakinra

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.

Also known as: Steriods

Methylprednisilone (steroids)

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Children's Hospital of Michigan: collaborator

Study Sites (2)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital Michigan

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Jain S, He F, Brown K, Burns JC, Tremoulet AH. Multisystem Inflammatory Syndrome therapies in children (MISTIC): A randomized trial. Contemp Clin Trials Commun. 2023 Apr;32:101060. doi: 10.1016/j.conctc.2023.101060. Epub 2023 Jan 20.

  PMID: 36694613 DERIVED

MeSH Terms

Interventions

Infliximab; CT-P13; Interleukin 1 Receptor Antagonist Protein; Methylprednisolone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Adriana Tremoulet
• Organization: UCSD

atremoulet@health.ucsd.edu

858-246-0012

Study Officials

• Adriana Tremoulet, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Kawasaki Disease Research Center Professor of Pediatrics

Model Details: This is a randomized trial of 3 treatment arms

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 24, 2021
• Study Start: December 22, 2020
• Primary Completion: December 22, 2023
• Study Completion: April 25, 2024
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)