Survey on inflammatory syndromes in children related to COVID-19
MultiOrgan Inflammatory Syndromes COVID-19 Related Study
This study is trying to gather information from hospitals about children in Poland who have had serious inflammatory conditions related to COVID-19 to better understand their symptoms and treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 2 sites (Warsaw and 1 other locations) |
| Trial ID | NCT04811456 on ClinicalTrials.gov |
What this trial studies
This observational study involves a nationwide, voluntary online survey aimed at collecting both retrospective and prospective data on multisystem inflammatory syndrome in children (MIS-C) in Poland. The study gathers anonymized patient data from pediatric hospitals across the country, focusing on children hospitalized since March 4, 2020, with conditions such as Kawasaki disease, toxic shock syndrome, or macrophage activation syndrome. Clinicians involved in the study received training on MIS-C, and data collection includes demographic information, clinical symptoms, and treatment outcomes, all evaluated using dedicated software.
Who should consider this trial
Good fit: Ideal candidates for this study are children who have been hospitalized with MIS-C or related inflammatory syndromes since March 4, 2020.
Not a fit: Patients with other infectious or non-infectious causes for their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding and management of MIS-C in children, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success in understanding MIS-C, but this specific approach of nationwide voluntary surveillance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Warsaw and 1 other locations
- Medical University of Warsaw Children's Hospital — Warsaw, Poland (Recruiting)
- Wroclaw Medical University — Wrocław, Poland (Recruiting)
Study contacts
- Principal investigator: Magdalena Okarska-Napierała — Medical University of Warsaw
- Study coordinator: Magdalena Okarska-Napierała, PhD
- Email: magda.okarska@gmail.com
- Phone: +48503065849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.