Combination Therapy for Multisystem Inflammatory Syndrome in Children
(MISTIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates the best combination of treatments to help children recover from Multisystem Inflammatory Syndrome in Children (MIS-C), a condition linked to COVID-19. MIS-C can cause symptoms such as fever, stomach issues, and heart problems. The trial tests three treatments: Anakinra (an immunosuppressive drug), Infliximab (a monoclonal antibody), and Methylprednisolone (a corticosteroid). Children who have had COVID-19 or were exposed to the virus, and show symptoms like fever and issues with two different body systems, might be suitable candidates.
As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering hope for effective recovery options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that anakinra holds promise for children with MIS-C, improving symptoms such as fever and heart function. Most children tolerated it well, with no major safety concerns reported.
Research has demonstrated that infliximab is safe for children with conditions like Kawasaki disease, which is similar to MIS-C. Infliximab reduced inflammation and improved heart health, with few safety issues noted.
Methylprednisolone, a type of steroid, has been used early in MIS-C treatment. Studies suggest it shortens hospital stays and is generally well-tolerated by children.
Overall, these treatments have demonstrated positive safety profiles in past studies, indicating they are generally safe for children with MIS-C.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Multisystem Inflammatory Syndrome in Children (MIS-C) because they offer unique approaches compared to standard treatments like intravenous immunoglobulin (IVIG) and aspirin. Anakinra, for example, targets specific inflammatory pathways by blocking the action of interleukin-1, a molecule that plays a significant role in inflammation. Infliximab is a monoclonal antibody that neutralizes tumor necrosis factor-alpha (TNF-alpha), another key player in inflammation, offering a different mechanism than the typical therapies. Methylprednisolone, a corticosteroid, provides a potent anti-inflammatory effect with a structured tapering plan that helps balance immediate relief and long-term management. These diverse mechanisms give researchers hope for more effective and faster-acting treatment options for MIS-C.
What evidence suggests that this trial's treatments could be effective for MIS-C?
This trial will compare the effectiveness of different treatments for children with Multisystem Inflammatory Syndrome (MIS-C). Studies have shown that each treatment in this trial may benefit children with MIS-C. Research indicates that infliximab, especially when combined with IVIG, can improve heart health, reduce inflammation quickly, and shorten ICU stays. Methylprednisolone, another treatment option, works well on its own and can be as effective as when combined with other treatments like IVIG. Anakinra, also under study, has shown good results in improving fever and heart issues, though it might lead to longer hospital stays for some patients. These medicines help manage symptoms by reducing inflammation, a key issue in MIS-C.23678
Who Is on the Research Team?
Adriana H Tremoulet, MD
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for children under 21 with Multisystem Inflammatory Syndrome-Children (MIS-C) after COVID-19 exposure. They must have fever and symptoms from two different systems like heart issues or skin changes, plus lab evidence of inflammation. Kids can't join if they have immune deficiencies or conditions that prevent them from taking the study meds.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
All MIS-C patients are initially treated with IVIG and receive additional therapy if they are severely ill or do not improve clinically.
Randomized Treatment
Participants are randomized to receive infliximab, steroids, or anakinra as further anti-inflammatory therapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including CRP reduction and left ventricular ejection fraction.
What Are the Treatments Tested in This Trial?
Interventions
- Anakinra
- Infliximab
- Methylprednisolone
Trial Overview
The study tests three treatments for MIS-C: Infliximab, Anakinra, and Methylprednisolone to see which helps kids recover fastest. It's not clear yet which combination works best since this condition is similar to Kawasaki disease but caused by COVID-19.
How Is the Trial Designed?
3
Treatment groups
Active Control
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
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.
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.
Anakinra is already approved in European Union, United States for the following indications:
- Rheumatoid arthritis
- Cryopyrin-associated periodic syndromes
- Deficiency of interleukin-1 receptor antagonist
- COVID-19
- Rheumatoid arthritis
- Deficiency of interleukin-1 receptor antagonist
- Neonatal-onset multisystem inflammatory disease (NOMID)
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
The Children's Foundation
Collaborator
Children's Hospital of Michigan
Collaborator
Published Research Related to This Trial
Citations
Outcomes of MIS-C patients treated with anakinra
In this retrospective cohort of severe MIS-C patients treated with anakinra we report favorable clinical outcomes with a low incidence of side effects. The ...
Impact of anakinra use on clinical outcomes in children ...
Of 138 children diagnosed with MIS-C, 79% had moderate or severe illness and 41% received anakinra. Of those, 31 patients who received anakinra ...
3.
rheumatologyadvisor.com
rheumatologyadvisor.com/home/topics/pediatric-rheumatology/anakinra-linked-to-longer-hospitalization-in-mis-c/Anakinra Linked to Longer Hospital Stay in Multisystem ...
Anakinra use was linked to an extended hospital stay among patients with moderate to severe multisystem inflammatory syndrome in children (MIS- ...
Clinical outcomes and safety of anakinra in the treatment of ...
Anakinra treatment, which was co-administered with IVIG primarily in patients with severe MIS-C, was associated with improvements in fever and cardiac function.
Variation in Early Anakinra Use and Short‐Term Outcomes in ...
We identified substantial variation in initial anakinra use in a real-world population of children with MIS-C, but no average short-term ...
Anakinra treatment in multisystemic inflammatory ...
Based on the results of the study, anakinra was associated with clinical improvements and was safe for most patients with refractory MIS-C.
Study Details | NCT00069329 | Anakinra to Treat Patients ...
This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID)
8.
acrabstracts.org
acrabstracts.org/abstract/outcomes-and-safety-of-anakinra-for-the-treatment-of-multisystem-inflammatory-syndrome-in-children/Outcomes and Safety of Anakinra for the Treatment ...
Conclusion: Treatment of MIS-C with anakinra was associated with resolution of symptoms, including fever and cardiovascular dysfunction, with no significant ...
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