NCT04898231

MIS-C Comparative Effectiveness Study

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multisystem Inflammatory Syndrome-Children

Interventions

Type	Name	Description
DRUG	Infliximab	Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
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.
DRUG	Methylprednisolone	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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2023-12-22
• Completion: 2024-04-25
• First posted: 2021-05-24
• Last updated: 2025-11-04
• Results posted: 2025-11-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study