MultiOrgan Inflammatory Syndromes COVID-19 Related Study

Recruiting

• Conditions: Covid19
• Interventions: Other: multisystem inflammatory syndrome in children (MIS-C)

• Registration Number: NCT04811456
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-25
• Status Verified: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-26
• Primary Completion: 2025-05-25
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIS-C	multisystem inflammatory syndrome in children (MIS-C)	Cases fulfilling following criteria: 1. fever ≥3 days 2. 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 3. elevated inflammatory markers AND 4. no other apparent microbial cause 5. 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

Primary Outcome Measures

Name	Time	Method
PICU	5 years	pediatric intensive care unit treatment need

Secondary Outcome Measures

Name	Time	Method
Heart dysfunction	5 years	Heart dysfunction is defined as ejection fraction (EF) of \<55% and severe heart dysfunction as EF \<35%.
CAA	5 years	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
Hypotension	5 years	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

Trial Locations

Locations (2)

Medical University of Warsaw Children's Hospital; 🇵🇱 Warsaw, Poland

Wroclaw Medical University; 🇵🇱 Wrocław, Poland