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Multisystem Inflammatory Syndrome therapies in children (MISTIC): A randomized trial
Sonia Jain1, Feng He1, Kiana Brown2
1Biostatistics Research Center, Herbert Wertheim School of Public Health and Human Longevity Science, University of California at San Diego, USA.
Insights
This clinical trial investigates the best anti-inflammatory treatments for Multisystem Inflammatory Syndrome in Children (MIS-C). Researchers are comparing therapies like steroids, anakinra, and infliximab to find the most effective treatment for MIS-C.
Area of Science:
- Pediatric infectious diseases
- Immunology
- Rheumatology
Background:
- Multisystem Inflammatory Syndrome in Children (MIS-C) emerged in early 2020 following SARS-CoV-2 infection.
- MIS-C presents with fever and severe inflammation, often necessitating intensive care.
- No definitive clinical trials have established optimal MIS-C treatment protocols.
Purpose of the Study:
- To compare the effectiveness of different anti-inflammatory treatments for MIS-C.
- To identify the optimal sequence of therapies for managing MIS-C.
- To inform evidence-based treatment guidelines for MIS-C.
Main Methods:
- A randomized, comparative effectiveness trial employing the small N Sequential Multiple Assignment Randomized Trial (snSMART) design.
- Participants initially received intravenous immunoglobulin (IVIG).
- Subsequent treatment randomization included steroids, anakinra, or infliximab, with re-randomization for non-responders.
Main Results:
- The trial is ongoing and actively enrolling participants.
- Data collection is focused on treatment efficacy and optimal therapeutic sequencing.
- Interim results are expected to guide treatment decisions.
Conclusions:
- The study aims to determine the most effective therapies and their optimal order for treating MIS-C.
- Enrollment continues to gather robust data on treatment outcomes.
- Findings will contribute to establishing best practices for MIS-C management.
Background:
Multisystem Inflammatory Syndrome in Children (MIS-C), which occurs 2-6 weeks after initial exposure to SARS-CoV-2, was first identified in early 2020 when patients presented with fever and significant inflammation, often requiring management in the intensive care unit. To date, there has been no clinical trial to determine the most effective treatment. This study compares anti-inflammatory treatments that were selected based on current treatments for Kawasaki disease, a coronary artery vasculitis that shares many clinical features with MIS-C.
Methods:
This randomized, comparative effectiveness trial of children with MIS-C uses the small N Sequential Multiple Assignment Randomized Trial (snSMART) design for rare diseases to compare multiple therapies within an individual. Study participants were treated first with intravenous immunoglobulin (IVIG), and if needed, subjects were then randomized to one of three additional treatments (steroids, anakinra, or infliximab). Participants were re-randomized to remaining treatments if they did not demonstrate clinical improvement.
Conclusion:
This trial continues to enroll eligible participants to determine the most effective therapies in addition to IVIG and best order in which to use them to treat MIS-C.
Trial Registration:
NCT04898231.
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