MultiOrgan Inflammatory Syndromes COVID-19 Related Study

NCT04811456 | Unknown

• 1 other identifier: MOIS-CoR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

MIS-C; PIMS-TS; COVID-19; hyperinflammation; children

Outcome Measures

Primary Outcomes (1)

• PICU

  pediatric intensive care unit treatment need

  5 years

Secondary Outcomes (3)

• Heart dysfunction

  5 years

• CAA

  5 years

• Hypotension

  5 years

Study Arms (1)

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

Other: multisystem inflammatory syndrome in children (MIS-C)

Interventions

multisystem inflammatory syndrome in children (MIS-C) OTHER

as in group description

MIS-C

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children aged 0-18 years old hospitalized with inflammatory conditions

You may qualify if:

• 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;

You may not qualify if:

• other infectious and non-infectious causes that could be responsible for the disease

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Wrocław Medical University: collaborator
• University of Warsaw: collaborator

Study Sites (2)

Medical University of Warsaw Children's Hospital

Warsaw, 02091, Poland

RECRUITING

Wroclaw Medical University

Wroclaw, 50-368, Poland

RECRUITING

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Magdalena Okarska-Napierała

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Okarska-Napierała, PhD

CONTACT

+48503065849; magda.okarska@gmail.com

Natalia Dudek, MD

CONTACT

natalia.dudek@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 23, 2021
• Study Start: May 25, 2020
• Primary Completion: May 25, 2025
• Study Completion: August 25, 2025
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

PL (2)