Trial Outcomes & Findings for MIS-C Comparative Effectiveness Study (NCT NCT04898231)
NCT ID: NCT04898231
Last Updated: 2025-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
73 participants
Primary outcome timeframe
1 week
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Infliximab
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Infliximab: Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
|
Methylprednisilone (steroids)
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.
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.
|
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.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MIS-C Comparative Effectiveness Study
Baseline characteristics by cohort
| Measure |
Infliximab
n=25 Participants
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Infliximab: Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
|
Methylprednisilone (steroids)
n=24 Participants
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.
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.
|
Anakinra
n=24 Participants
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: 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.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=15 Participants
|
24 Participants
n=161 Participants
|
24 Participants
n=100 Participants
|
73 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
7.1 years
n=15 Participants
|
7.95 years
n=161 Participants
|
6.78 years
n=100 Participants
|
7.64 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
11 Participants
n=161 Participants
|
9 Participants
n=100 Participants
|
28 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=15 Participants
|
13 Participants
n=161 Participants
|
15 Participants
n=100 Participants
|
45 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=15 Participants
|
20 Participants
n=161 Participants
|
19 Participants
n=100 Participants
|
54 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=15 Participants
|
24 participants
n=161 Participants
|
24 participants
n=100 Participants
|
73 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 1 weekThe 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.
Outcome measures
| Measure |
Infliximab
n=25 Participants
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Infliximab: Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
|
Methylprednisilone (steroids)
n=24 Participants
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.
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.
|
Anakinra
n=22 Participants
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: 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.
|
|---|---|---|---|
|
Number of Participants Needing Additional Anti-inflammatory Therapy Within the First Week of First Randomization
|
10 Participants
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 weeksOf the three initial randomization arms (infliximab, steroids or anakinra), the rate of adverse events will be compared. The goal is to determine which arm has the lowest rate of adverse events. The AEs reported in the AE section include: All Cause, SAE and Others.
Outcome measures
| Measure |
Infliximab
n=25 Participants
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Infliximab: Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
|
Methylprednisilone (steroids)
n=24 Participants
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.
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.
|
Anakinra
n=22 Participants
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: 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.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
16 Participants
|
1 Participants
|
Adverse Events
Infliximab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylprednisilone (steroids)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Anakinra
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Infliximab
n=25 participants at risk
Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
Infliximab: Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
|
Methylprednisilone (steroids)
n=24 participants at risk
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.
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.
|
Anakinra
n=22 participants at risk
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: 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.
|
|---|---|---|---|
|
Nervous system disorders
Night Terrors
|
0.00%
0/25 • 6 weeks
|
4.2%
1/24 • Number of events 1 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
MRSA Skin Infection
|
0.00%
0/25 • 6 weeks
|
4.2%
1/24 • Number of events 1 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25 • 6 weeks
|
37.5%
9/24 • Number of events 9 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/25 • 6 weeks
|
4.2%
1/24 • Number of events 1 • 6 weeks
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
|
Hepatobiliary disorders
Increased ALT
|
0.00%
0/25 • 6 weeks
|
8.3%
2/24 • Number of events 2 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/25 • 6 weeks
|
8.3%
2/24 • Number of events 2 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place