MIS-C Associated With COVID-19MIS-C IDEANCT07881068
Genetic Basis of SARS-CoV-2 Infection-Associated Multisystem Inflammatory Syndrome in Children (MIS-C)
An observational study of MIS-C Associated With COVID-19, run by Istituto Giannina Gaslini at 3 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- MIS-C Associated With COVID-19
- How many people
- 150 participants
- Where
- 3 sitesItaly
- Study dates
- 23 Feb 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: 50 patients presenting with clinical features characteristic of MIS-C and Kawasaki disease, and their respective parents
Who may be able to join
- Patients presenting with specific clinical features characteristic of MIS-C and Kawasaki disease.
Who cannot join
- Patients presenting with other diseases.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo
Lucio Verdoni
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Alessandro Aiuti
- Recruiting
IRCCS Materno-Infantile Burlo Garofolo
Trieste
Paolo Gasparini
About this study
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.
- Conditions
- MIS-C Associated With COVID-19
- Medical subject headings
- pediatric multisystem inflammatory disease, COVID-19 related
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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:
- 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start23 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MIS-C Associated With COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881068
- Sponsor's protocol ID
- MIS-C IDEA (12003)
- Acronym
- MIS-C IDEA
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of SARS-CoV-2 Infection-Associated Multisystem Inflammatory Syndrome in Children (MIS-C)
- ClinicalTrials.gov ID
- NCT07881068
- Acronym / sponsor ID
- MIS-C IDEA / MIS-C IDEA (12003)
- Conditions
- MIS-C Associated With COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 50 patients presenting with clinical features characteristic of MIS-C and Kawasaki disease, and their respective parents
Key inclusion criteria (1 listed)
- Patients presenting with specific clinical features characteristic of MIS-C and Kawasaki disease.
Key exclusion criteria (1 listed)
- Patients presenting with other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical and laboratory characterization of cases enrolled at the IRCCS institutions within the IDEA Network
Time frame: month 9
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
Whole-genome sequencing of 50 patient-parent trios.
Time frame: Month 12
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.
Validation of Identified Variants
Time frame: Month 12
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MIS-C Associated With COVID-19, run by Istituto Giannina Gaslini at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelo Ravelli (+3901056363915, angeloravelli@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and laboratory characterization of cases enrolled at the IRCCS institutions within the IDEA Network (time frame: month 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.