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NCT04538495 · ClinicalTrials.gov registry record
Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease
A clinical trial, sponsored by University of California, San Diego.
- Completed
- Registry status
- 268
- Enrollment target
NCT04538495: Completed study, sponsored by University of California, San Diego.
NCT04538495 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 268 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04538495 has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 268 participants
- Enrollment target
Study Summary
Beginning in mid-March 2020, pediatricians in communities in Western Europe, the UK, and the Eastern U.S. that had been severely affected by the Covid-19 pandemic noted an increased number of children presenting with fever and evidence of severe inflammation who required admission to intensive care. The syndrome was branded by the CDC in the U.S. as Multisystem Inflammatory Syndrome in Children (MIS-C). The most severely affected children presented with heart failure leading to shock and the absence of significant pulmonary disease. The clinical presentation in these patients shared many features with Kawasaki disease (KD), a self-limited pediatric vasculitis that can result in coronary artery aneurysms.The inflammatory markers, however, were much higher even than KD shock syndrome, a variant of KD presenting with distributive shock and requiring inotropic and vasoactive support in the ICU. Some patients were polymerase chain reaction (PCR)+ for SARS-CoV-2 while most were virus-negative but had detectable antibody suggesting that MIS-C was an immune-mediated reaction to antecedent exposure to the virus. While patients were being diagnosed with shock and MIS-C, children with a milder version of MIS-C that shared many features of KD were being diagnosed in these same regions.
Primary Outcome
Collection of clinical data and patient samples from children with MIS-C and KD to understand the relationship between these two conditions.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2022-03-31 |
What the finished NCT04538495 record still lists
NCT04538495 is an observational study that tracks outcomes without assigning an intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04538495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04538495 about?
NCT04538495 is a clinical study titled "Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease". Beginning in mid-March 2020, pediatricians in communities in Western Europe, the UK, and the Eastern U.S. that had been severely affected by the Covid-19 pandemic noted an increased number of children presenting with fever and evidence of severe inflammation who required admission to intensive care....
What is the current status of trial NCT04538495?
This trial is currently completed. The enrollment target is 268 participants. The study started on 2020-08-01. Estimated completion is 2022-03-31.
Who is sponsoring clinical trial NCT04538495?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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