Seroprevalence of SARS-Cov-2 Antibodies in Children

Completed

Conditions: COVID
Corona Virus Infection
Multisystem Inflammatory Syndrome in Children

Interventions: Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
Other: Blood Storage

Registration Number: NCT04347408

Lead Sponsor: Queen's University, Belfast

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1100

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serious Infection	Covid-19 Antibody testing (IgG and IgM)	Children admitted to hospital with serious infections
Healthy Children	Covid-19 Antibody testing (IgG and IgM)	Healthy children of healthcare workers between 2 and 15 years of age
Healthy Children	Blood Storage	Healthy children of healthcare workers between 2 and 15 years of age
Paediatric Multisystem Inflammatory Syndrome	Covid-19 Antibody testing (IgG and IgM)	Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome
Paediatric Multisystem Inflammatory Syndrome	Blood Storage	Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome
Serious Infection	Blood Storage	Children admitted to hospital with serious infections

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Brain Natriuretic Peptide	6 months	Cardiac enzyme
Echocardiogram Ejection Fraction	6 months	Measure of cardiac function
High-sensitivity Cardiac Troponin Test	6 months	Cardiac Enzyme

Trial Locations

Locations (4): Public Health England
🇬🇧
Manchester, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧
Belfast, United Kingdom
University Hospital of Wales
🇬🇧
Cardiff, United Kingdom
Royal Hospital for Children
🇬🇧
Glasgow, United Kingdom