Your session is about to expire
← Back to Search
Interleukin-1 receptor antagonist
Combination Therapy for Multisystem Inflammatory Syndrome in Children (MISTIC Trial)
Phase 2 & 3
Waitlist Available
Led By Adriana Tremoulet, MD, MAS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
MISTIC Trial Summary
This trial is investigating whether a combination of therapies is more effective than a single therapy in treating children with a condition called Multisystem Inflammatory Syndrome-Children (MIS-C) who have been exposed to the virus that causes COVID-19.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions, infections due to weakened immunity, digestive problems, liver issues, blood disorders, and potential impact on growth in children. Each medication has its own set of possible side effects.
MISTIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-inflammatory treatment regimen lowest rate of second randomization
Secondary outcome measures
Therapeutic procedure
Anti-inflammatory treatment regimen fewest adverse events
Anti-inflammatory treatment regimen quickest return of left ventricular ejection fraction
MISTIC Trial Design
3Treatment groups
Active Control
Group I: InfliximabActive Control1 Intervention
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Group II: Methylprednisilone (steroids)Active Control1 Intervention
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.
Group III: AnakinraActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
The Children's FoundationUNKNOWN
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,227 Total Patients Enrolled
Children's Hospital of MichiganOTHER
25 Previous Clinical Trials
4,113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a weakened immune system.You experience severe stomach pain, diarrhea, nausea, or vomiting.You have swelling in your lymph nodes (neck or elsewhere).You have redness and swelling in your eyes, extremities, lips or tongue, or a skin rash.You have symptoms affecting the nervous system such as confusion, weakness on one side of the body, headache, or sensitivity to light.
Research Study Groups:
This trial has the following groups:- Group 1: Infliximab
- Group 2: Methylprednisilone (steroids)
- Group 3: Anakinra
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies for this research project?
"That is correct. If you consult the clinicaltrials.gov website, you will see that this study is still looking for volunteers. This particular trial was first posted on December 22, 2020 and was last updated on March 28, 2022. They are hoping to find 180 people total to participate at 2 different locations."
Answered by AI
What is the body of research for Infliximab?
"There are a total of 230 Infliximab studies, with 53 of them being Phase 3 clinical trials. The majority of these studies are based in Duarte, California; however, there are 7528 total locations running these trials."
Answered by AI
What medical conditions is Infliximab usually used to treat?
"Infusion with infliximab is a standard treatment for scalp structure. However, it has also shown to be an effective method of managing psoriasis, nomid, and ulcerative colitis."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger