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Genetic Risk factors for Multi-system Inflammatory Syndrome in Children and Pediatric Post COVID condition (GRIP)

Genetic Risk factors for Multi-system Inflammatory Syndrome in Children and Pediatric Post COVID condition (GRIP) - GRIP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53446
Enrollment
400
Registered
2022-06-28
Start date
2022-10-07
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MIS-C and Post-COVID

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1. Children with a history of MIS-C: as defined according to WHO criteria [36], who were 0-18 at the time of MIS-C 2. Children with post-COVID condition who were 0-18 at the time of SARS-CoV-2 infection: as defined according to the WHO case definition [37]. This includes a history of probable or confirmed prior SARS-CoV-2 infection, with signs and symptoms (including fatigue, shortness of breath, cognitive dysfunction) that are present after 12 weeks, last at least 2 months, have an impact on daily functioning and are not explained by an alternative diagnosis. Post-COVID condition must be diagnosed by a pediatrician. 3. *Exposed* control group: children with a history of proven SARS-CoV-2 infection (RT-PCR, antigen test or serology positive) who were 0-18 at the time of SARS-CoV-2 infection.

Exclusion criteria

Exclusion criteria: 1. Group 1 (MIS-C): no specific exclusion criteria 2. Group 2 (post-COVID condition): other plausible cause of symptoms AND/OR a history compatible with chronic fatigue syndrome prior to infection with SARS-CoV-2. Children with a history of MIS-C who suffer prolonged signs and symptoms will be included in the MIS-C group. Patients who were not diagnosed with Post-COVID condition by a pediatrician, but only by for example a general practitioner, are excluded. 3. Group 3 (*exposed* control group): MIS-C or post-COVID condition; AND/OR Moderate or severe course of COVID-19, defined as: need for supplemental oxygen and/or intensive care admission because of COVID-19 and/or death. Children are also excluded when they have had a vaccination against SARS-CoV-2, before their first infection with this virus. Also, the children in de the exposed control group are excluded when their parents/siblings (1st degree family) suffer(-ed) from MIS-C or post-COVID condition.

Design outcomes

Primary

MeasureTime frame
- Individual analysis of immunological genes in cases only: We will restrict our analysis to pathogenic (class 5) or likely pathogenic (class 4) variants in genes known to be associated with monogenic inborn errors of immunity to diagnose previously unsuspected inborn errors of immunity (IEI) in MIS-C or post-COVID condition cases. - Case-control study: We will evaluate if a larger proportion of cases with MIS-C or post-COVID condition have rare and presumably deleterious variants in immunological genes than children with an asymptomatic or mild infection.

Secondary

MeasureTime frame
We will evaluate if genetic variants correlate with clinical parameters, such as severity of illness and response to treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)