COVID-19 in children
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: - age up to and including 17 years - clinical or microbiological diagnosis of COVID-19 or MIS-C - presentation in hospital (outpatient department, emergency department, or clinical admission) Study population of the substudy on reinfections: enrolled participants of the initial studies COPP/COPP-IMM will be approached to also participate in the current substudy. Inclusion criteria for this substudy: - Children with a prior COVID-19 infection and/or MIS-C, treated as in- or outpatients in Dutch hospitals, AND - Previously included in the COPP/COPP-IMM study between 1st of March 2020 and 1st of September 2022, with consent to be approached for subsequent studies, AND - Informed consent for the reinfection substudy
Exclusion criteria
Exclusion criteria: Age 18 years or older No COVID-19 or MIS-C No informed consent For blood sampling: body weight under 3 kg Exclusion criteria for the substudy on reinfections A potential subject who meets any of the following criteria will be excluded from - No consent from guardians and/or patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will perform detailed immunological analyses in a two-tiered approach. In the first tier we will do a rapid, more general assessment of the immune system. This will include a detailed phenotypical analysis of the cells of the innate and adaptive immune system using spectral flow cytometry, a multiplex analysis of inflammatory cytokines using Luminex bead arrays and a quantitative and qualitative analysis of anti-SARS-CoV-2 antibodies. Depending on the results of the investigations in the first tier, we will choose which in-depth immunological analyses will be done in the second tier. Investigations in the second tier will focus on the innate immune system, the adaptive immune system (either T-cell responses or B-cell responses) and/or biomarker discovery of serum proteins. Main study parameter/endpoints of the reinfection substudy 1. To determine the incidence rate of reinfections with SARS-CoV-2. 2. To investigate risk factors (demographic, clinical, virological, immunological) for SARS-CoV-2 reinfections. 3. To understand which factors determine the longevity and breadth of protective SARS-CoV-2-specific humoral immunity. 4. To determine the health impact of SARS-CoV-2 reinfections or their sequelae. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will correlate the immunological profiles with detailed clinical outcome measures of the patients. We will collect these clinical outcome measures in the same manner as in our related cohort study *Clinical features of COVID-19 in Pediatric Patients* (COPP-study). Clinical parameters collected include: severity of disease (need of supplemental oxygen); underlying illnesses; age at presentation; clinical syndrome; laboratory parameters at diagnosis and during illness; response to treatment; clinical outcome, and patient reported outcome measures at 6 weeks follow-up. Secondary study parameter/endpoints of the reinfection substudy To determine the incidence rate of (co-)infections (such as influenza viruses and RSV). | — |
Countries
Netherlands
Outcome results
None listed