MultiOrgan Inflammatory Syndromes COVID-19 Related Study

Study Overview
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Brief Summary
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The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.

Detailed Description
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The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians. KD and aKD were defined following the American Heart Association (AHA) guidelines. TSS was established based on modified criteria by the Centers for Disease Control and Prevention. MAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification. The definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation. For patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected. All study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.

Official Title
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MultiOrgan Inflammatory Syndromes COVID-19 Related Study

Conditions
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Covid19

Intervention / Treatment
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* Other: multisystem inflammatory syndrome in children (MIS-C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who required hospitalization since 4th March 2020; diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome; Exclusion Criteria: other infectious and non-infectious causes that could be responsible for the disease SARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIS-C<br>Cases fulfilling following criteria: fever ≥3 days at least two of the following: rash or bilateral conjunctivitis or mucocutaneous inflammation signs hypotension features of myocardial dysfunction, pericarditis, or coronary artery abnormality, based on echocardiographic findings or elevated B-type natriuretic peptide (BNP)/N-terminal-pro-BNP (NT-proBNP) or troponin evidence of coagulopathy acute gastrointestinal problems elevated inflammatory markers AND no other apparent microbial cause evidence of COVID-19 (positive real-time polymerase chain reaction, antigen test or serology), or personal history of COVID-19 or contact with a proven COVID-19 case | Other: multisystem inflammatory syndrome in children (MIS-C)<br>* as in group description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PICU | pediatric intensive care unit treatment need | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart dysfunction | Heart dysfunction is defined as ejection fraction (EF) of <55% and severe heart dysfunction as EF <35%. | 5 years | 
| CAA | Coronary artery abnormalities comprise both coronary dilation and/or coronary aneurysm. Dilation was defined by Z-score between 2 to 2.5, while aneurysm by Z score ≥2.5 | 5 years | 
| Hypotension | Hypotension is defined by a minimal systolic blood pressure (sBP) below 70+2×age (in years) mmHg or below 90 mmHg for children >10 years old | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIS-C, PIMS-TS, COVID-19, hyperinflammation, children