Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 268 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2020-08-01
Est. Completion 2022-03-31

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT04538495

The ClinicalTrials.gov registry entry for NCT04538495 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT04538495 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.