MultiOrgan Inflammatory Syndromes COVID-19 Related Study

Covid19 Clinical Trial

— MOIS-CoR  

Official title:

MultiOrgan Inflammatory Syndromes COVID-19 Related Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811456
• Other study ID #: MOIS-CoR
• Status: Recruiting
• Start date: May 25, 2020
• Est. completion date: August 25, 2025

Study information

• Verified date: March 2021
• Source: Medical University of Warsaw
• Contact: Magdalena Okarska-Napierala, PhD
• Phone: +48503065849
• Email: magda.okarska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 25, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• multisystem inflammatory syndrome in children (MIS-C)
as in group description

Locations

Country	Name	City	State
Poland	Medical University of Warsaw Children's Hospital	Warsaw
Poland	Wroclaw Medical University	Wroclaw

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Warsaw	University of Warsaw, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PICU	pediatric intensive care unit treatment need	5 years
Secondary	Heart dysfunction	Heart dysfunction is defined as ejection fraction (EF) of <55% and severe heart dysfunction as EF <35%.	5 years
Secondary	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
Secondary	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