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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04538495
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : November 16, 2021
Information provided by (Responsible Party):
Jane C. Burns MD, University of California, San Diego

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.

Condition or disease
Kawasaki Disease Inflammation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

Primary Outcome Measures :
  1. Collection of clinical data and patient samples from children with MIS-C and KD to [ Time Frame: We will collect demographic and clinical data on all KD patients at participating sites throughout the 8-month study period. ]
    Collection of clinical data and patient samples from children with MIS-C and KD to understand the relationship between these two conditions.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion criteria:

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

Exclusion Criteria:

• All patients with pre-existing major medical conditions will be excluded. This includes patients with known genetic disorders (e.g. trisomy 21, cystic fibrosis), conditions requiring continuous medication (e.g. seizure disorder, heart disease), or known immune disorder (e.g. hypogammaglobulinemia, complement deficiency). Patients with asthma or atopic dermatitis will not be excluded unless patients have received oral steroids in the previous week. Obesity is not an exclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04538495

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Contact: Jane C Burns 858-246-0155
Contact: Adriana H Tremoulet 858-246-0012

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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Jane C Burns, MD    858-246-0155   
Contact: Adriana H Tremoulet, MD    858-966-0012   
Sponsors and Collaborators
University of California, San Diego
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Principal Investigator: Jane C Burns University of California, San Diego
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Responsible Party: Jane C. Burns MD, Principal Investigator, University of California, San Diego Identifier: NCT04538495    
Other Study ID Numbers: CER-1602-34473
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases