Clinical trial

Genetic Risk Factors for Multi-system Inflammatory Syndrome in Children and Pediatric Post COVID Condition

Name
NL80853.058.22
Description
We will perform Whole Exome Sequencing on DNA from saliva. We will include: Children with a history of MIS-C; children with post-COVID condition; and controls in order to identify rare, high impact genetic variants in immunological genes and pathways in children with a history of MIS-C or pediatric post-COVID condition.
Trial arms
Trial start
2022-06-28
Estimated PCD
2024-01-31
Trial end
2024-01-31
Status
Recruiting
Treatment
Saliva collection at home
Children (with help of their parents) collect their saliva with a saliva collection kit which they send to our research center.
Arms:
Control, MIS-C, Post COVID-Condition
Size
400
Primary endpoint
Quantity and quality of genetic variants in immunological genes between study groups.
2 year
Eligibility criteria
Inclusion Criteria: 1. Children (\<19 years) with a history of MIS-C: as defined according to WHO criteria. 2. Children (\<19 years) with post-COVID condition: as defined according to the WHO case definition. 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. 3. 'Exposed' control group: children (\<19 years of age): a history of proven SARS-CoV-2 infection (RT-PCR, antigen test or serology positive). If the child has been vaccinated against SARS-CoV-2, the first documented infection must have been prior to the vaccination. Exclusion Criteria: 1. No informed consent 2. Group 1 (MIS-C): no specific exclusion criteria 3. 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. 4. Group 3 ('exposed' control group): MIS-C or post-COVID condition; AND/OR Moderate or severe course of COVID-19, as defined in the COPP-study (N20.043) (need for supplemental oxygen and/or intensive care admission because of COVID-19 and/or death) AND/OR first degree relative with long COVID or MIS-C.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-02-10

1 organization

1 product

7 indications

Indication
COVID-19
Indication
MIS-C