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

NCT05722717 | Unknown

• 1 other identifier: NL80853.058.22
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Post-Acute COVID-19; Post-Acute COVID19 Syndrome; Multi-System Inflammatory Syndrome in Children; Pediatric Inflammatory Multisystem Syndrome; Post COVID-19 Condition; Post-COVID-19 Syndrome

Keywords

COVID-19; Post-COVID Condition; MIS-C; PIMS-TS

Outcome Measures

Primary Outcomes (1)

• Quantity and quality of genetic variants in immunological genes between study groups.

  We want to quantify how many immunogenic variants are found between the groups and identify which variants/genes these are.

  2 year

Secondary Outcomes (1)

• Correlate genetic findings with clinical characteristics

  2 year

Study Arms (3)

MIS-C

Children with a history of MIS-C: as defined according to WHO criteria, who were 0-18 at the time of MIS-C.

Genetic: Saliva collection at home

Post COVID-Condition

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.

Genetic: Saliva collection at home

Control

'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.

Genetic: Saliva collection at home

Interventions

Saliva collection at home GENETIC

Children (with help of their parents) collect their saliva with a saliva collection kit which they send to our research center.

Control; MIS-C; Post COVID-Condition

Eligibility Criteria

• Age: 0 Months - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with a history of MIS-C or Post-COVID Condition and children with a known SARS-CoV-2 infection without severe disease course.

You may qualify if:

• Children (\<19 years) with a history of MIS-C: as defined according to WHO criteria.
• 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.
• '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.

You may not qualify if:

• No informed consent
• 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.
• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• University Medical Center Groningen: collaborator
• UMC Utrecht: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; pediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmeline P Buddingh, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam J Tulling, MD

CONTACT

629843439; a.j.tulling@lumc.nl

Emmeline P Buddingh, MD, PhD

CONTACT

715262822; E.P.Buddingh@lumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. E.P. Buddingh

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 10, 2023
• Study Start: June 28, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

NL (1)