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NCT04898231 · ClinicalTrials.gov registry record · Phase 2
MIS-C Comparative Effectiveness Study
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT04898231: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT04898231 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04898231, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Methylprednisolone
- DRUG Infliximab
- DRUG Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 2 |
What the finished NCT04898231 record still lists
NCT04898231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Methylprednisolone is the first listed.
NCT04898231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04898231 about?
NCT04898231 is a clinical study titled "MIS-C Comparative Effectiveness Study". 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 I...
What is the current status of trial NCT04898231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2020-12-22. Estimated completion is 2024-04-25.
What interventions are being tested in trial NCT04898231?
The interventions under investigation include: Methylprednisolone (DRUG), Infliximab (DRUG), Anakinra (DRUG).
Who is sponsoring clinical trial NCT04898231?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04898231's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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