Study Results
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View full resultsBasic Information
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COMPLETED
1100 participants
OBSERVATIONAL
2020-05-06
2023-11-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Blood Storage
Storage of blood for multi-omics analysis
Paediatric Multisystem Inflammatory Syndrome
Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome
Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Blood Storage
Storage of blood for multi-omics analysis
Serious Infection
Children admitted to hospital with serious infections
Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Blood Storage
Storage of blood for multi-omics analysis
Interventions
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Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Blood Storage
Storage of blood for multi-omics analysis
Eligibility Criteria
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Exclusion Criteria
Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.
1 Month
15 Years
ALL
Yes
Sponsors
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Belfast Health and Social Care Trust
OTHER
Queen's University, Belfast
OTHER
Responsible Party
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Thomas Waterfield
Chief Investigator and Academic Clinical Lecturer
Principal Investigators
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Thomas Waterfield, BMBCh
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Locations
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Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
Public Health England
London, , United Kingdom
Public Health England
Manchester, , United Kingdom
Countries
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References
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Waterfield T, Watson C, Moore R, Ferris K, Tonry C, Watt A, McGinn C, Foster S, Evans J, Lyttle MD, Ahmad S, Ladhani S, Corr M, McFetridge L, Mitchell H, Brown K, Amirthalingam G, Maney JA, Christie S. Seroprevalence of SARS-CoV-2 antibodies in children: a prospective multicentre cohort study. Arch Dis Child. 2021 Jul;106(7):680-686. doi: 10.1136/archdischild-2020-320558. Epub 2020 Nov 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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282617
Identifier Type: -
Identifier Source: org_study_id