Characterization of Multisystem Inflammatory Syndrome in Children (MIS-C) and Its Relationship to Kawasaki Disease
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ClinicalTrials.gov Identifier: NCT04538495 |
Recruitment Status :
Recruiting
First Posted : September 4, 2020
Last Update Posted : November 16, 2021
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Condition or disease |
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Kawasaki Disease Inflammation |

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 |

- 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.

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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 |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT04538495
Contact: Jane C Burns | 858-246-0155 | jcburns@health.ucsd.edu | |
Contact: Adriana H Tremoulet | 858-246-0012 | atremoulet@health.ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Contact: Jane C Burns, MD 858-246-0155 jcburns@health.ucsd.edu | |
Contact: Adriana H Tremoulet, MD 858-966-0012 atremoulet@health.ucsd.edu |
Principal Investigator: | Jane C Burns | University of California, San Diego |
Responsible Party: | Jane C. Burns MD, Principal Investigator, University of California, San Diego |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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