Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease

NCT04538495 | Completed DMC

• 1 other identifier: CER-1602-34473
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kawasaki Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• Collection of clinical data and patient samples from children with MIS-C and KD to

  Collection of clinical data and patient samples from children with MIS-C and KD to understand the relationship between these two conditions.

  We will collect demographic and clinical data on all KD patients at participating sites throughout the 8-month study period.

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to enroll 100 MIS-C subjects in this study to allow for the collection of data and samples that will support the many different aims in this study.

You may qualify if:

• The following patients (age 1 mos. through young adults) will be recruited for this study:
• Patients who meet the CDC definition for MIS-C:
• Patients presenting with fever (\>38C for \>24 h - also by subjective report), laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (\>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
• No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or suspected COVID-19 exposure within the 4 weeks prior to the onset of symptoms
• Patients who meet the CDC definition for MIS-C and require care in the PICU

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

12.5 cc of blood (2.5 teaspoons) (for RNA studies, plasma protein studies, serum antibody measurement, and in vitro studies of PBMC and cultured HUVECs) will be drawn when phlebotomy is performed for routine clinical care from MIS-C. This will be at 3 timepoints: admission (pre-treatment), after treatment but before discharge, at the clinic visit between 1 to 6 weeks after discharge. Whole blood RNA will be collected in PAXgene tubes. Rectal swab or stool for SARS-CoV-2 PCR testing in the Burns Lab at UCSD will be collected only once at the time of admission. For sites able/willing to participate in live cell collection, heparinized blood (green top tubes) for PBMC and neutrophil studies.

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jane C Burns

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 4, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: March 31, 2022
• Last Updated: August 1, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)