An observational study in MIS-C Associated With COVID-19, sponsored by Istituto Giannina Gaslini. Recruiting at 3 sites in Italy. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Istituto Giannina Gaslini · Observational
The project aims to investigate the molecular basis of pediatric inflammatory conditions associated with COVID-19 identified by the IDEA network, with the objectives of characterizing their genetic background, pathophysiology, and clinical spectrum, improving therapeutic strategies, defining follow-up programs, and identifying individuals at risk.
29 studies on the registry are indexed under pediatric multisystem inflammatory disease, COVID-19 related; 8 are open to participants now.
This study's planned enrollment of 150 is below the median of 212 across 22 observational studies indexed under pediatric multisystem inflammatory disease, COVID-19 related.
Browse pediatric multisystem inflammatory disease, COVID-19 related studies →Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
50 patients presenting with clinical features characteristic of MIS-C and Kawasaki disease, and their respective parents
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinical and laboratory characterization of cases enrolled at the IRCCS institutions within the IDEA Network
Clinical and laboratory data from patients enrolled at the different IRCCS institutions within the IDEA Network will be collected in a standardized manner using a dedicated clinical data collection form. The collected cases will then be jointly reviewed to assess their eligibility for subsequent analyses. A total of 50 cases will be selected for genomic analyses
Time frame: month 9
Whole-genome sequencing of 50 patient-parent trios.
Identification of candidate genes associated with susceptibility to COVID-19-associated MIS-C and Kawasaki disease. If genomic analysis does not confirm the involvement of single-gene variants in the pathogenesis of MIS-C, an oligogenic and/or multifactorial mechanism should be considered.
Time frame: Month 12
Validation of Identified Variants
Following the identification of candidate genes, functional validation will be performed using complementary in silico and in vitro approaches, based on technologies, methodologies, and expertise already available at the participating institutions. In particular, the following studies will be conducted: i) Gene expression studies of candidate genes in patient cells; ii) Generation of mutant cell lines (KO or variant-bearing cell lines) using genome-editing technologies; iii) Transduction of KO cell lines for the gene of interest with viral vectors encoding either the gene carrying the putative pathogenic variant or the wild-type gene; iv) Cellular localization studies of variants considered to be of pathogenic relevance. Patients and their family members will also undergo immunological characterization, with particular focus on mechanisms associated with the inflammatory response and adaptive immunity.
Time frame: Month 12
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Dec 2026, 58 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
pediatric multisystem inflammatory disease, COVID-19 related →
Istituto Giannina Gaslini