Corona Virus Infection, COVID, Multisystem Inflammatory Syndrome in Children
Conditions
Keywords
antibodies
Brief summary
It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.
Detailed description
Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome. The majority of coronaviruses cause disease in a specific host species but some have infected humans by cross-species transmission. This process has led to a number of severe outbreaks of human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East respiratory syndrome (MERS) in 2012. From December 2019 a novel infection severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the causal factor in a growing number of severe cases of pneumonia. This disease was subsequently named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe disease is associated with pneumonia and damage to vital organs including lung, heart, liver, and kidney. Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children. The social distancing measures in the United Kingdom include the closure of schools and the cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to have a profound effect on the well-being of children. This study is required to determine what proportion of children have been exposed to SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study could be used to inform public health decisions regarding the re-opening of schools and other services vital to the well-being of children. In addition the study will recruit children with paediatric multi-system inflammatory syndrome admitted to the Royal Belfast Hospital for Sick Children along with matched controls with other infections.
Interventions
DIAGNOSTIC_TESTCovid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
OTHERBlood Storage
Storage of blood for multi-omics analysis
Sponsors
Belfast Health and Social Care Trust
Queen's University, Belfast
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy children of healthcare professionals.
Exclusion criteria
Not currently receiving antibiotics, not admitted to hospital within the last seven days, not receiving immunosuppressive drugs and never diagnosed with a malignancy. Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunoglobulins (G and M) to SARS-Cov2 in Plasma | 6 months | • Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram Ejection Fraction | 6 months | Measure of cardiac function |
| High-sensitivity Cardiac Troponin Test | 6 months | Cardiac Enzyme |
| Brain Natriuretic Peptide | 6 months | Cardiac enzyme |
Countries
United Kingdom
Participant flow
Recruitment details
In total, 1042 potential participants were screened for inclusion, of whom 50 were excluded; 18 were outside the specified age range, 1 met specific exclusion criteria,16 declined consent and 15 did not undergo phlebotomy. In total 992 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Children Healthy children of healthcare workers between 2 and 15 years of age
Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19 | 992 |
| Total | 992 |
Baseline characteristics
| Characteristic | Healthy Children | — |
|---|---|---|
| Age, Continuous | 10.1 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 483 Participants | — |
| Sex: Female, Male Male | 509 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Immunoglobulins (G and M) to SARS-Cov2 in Plasma
• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
Time frame: 6 months
Population: Healthy children of healthcare workers between 2 and 15 years of age
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Healthy Children | Immunoglobulins (G and M) to SARS-Cov2 in Plasma | Abbott SARS-CoV-2 IgG Assay (Index S/C) | 4.86 Titres |
| Healthy Children | Immunoglobulins (G and M) to SARS-Cov2 in Plasma | Elecys Roche SARS-CoV-2 (Cut-Off-Index COI) | 65.32 Titres |
| Healthy Children | Immunoglobulins (G and M) to SARS-Cov2 in Plasma | Diasorin Liason SARS-CoV-2 IgM (arbitrary units A/U) | 64.17 Titres |
Secondary
Brain Natriuretic Peptide
Cardiac enzyme
Time frame: 6 months
Secondary
Echocardiogram Ejection Fraction
Measure of cardiac function
Time frame: 6 months
Secondary
High-sensitivity Cardiac Troponin Test
Cardiac Enzyme
Time frame: 6 months