Seroprevalence of SARS-Cov-2 Antibodies in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study

Conditions
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COVID, Corona Virus Infection, Multisystem Inflammatory Syndrome in Children

Intervention / Treatment
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* Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
* Other: Blood Storage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Children<br>Healthy children of healthcare workers between 2 and 15 years of age | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)<br>* Antibody testing for previous exposure to Covid-19<br>Other: Blood Storage<br>* Storage of blood for multi-omics analysis<br>|
| Paediatric Multisystem Inflammatory Syndrome<br>Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)<br>* Antibody testing for previous exposure to Covid-19<br>Other: Blood Storage<br>* Storage of blood for multi-omics analysis<br>|
| Serious Infection<br>Children admitted to hospital with serious infections | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)<br>* Antibody testing for previous exposure to Covid-19<br>Other: Blood Storage<br>* Storage of blood for multi-omics analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiogram Ejection Fraction | Measure of cardiac function | 6 months | 
| High-sensitivity Cardiac Troponin Test | Cardiac Enzyme | 6 months | 
| Brain Natriuretic Peptide | Cardiac enzyme | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibodies