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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Children | Healthy children of healthcare workers between 2 and 15 years of age |
| |
| Paediatric Multisystem Inflammatory Syndrome | Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome |
| |
| Serious Infection | Children admitted to hospital with serious infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 Antibody testing (IgG and IgM) | Diagnostic Test | Antibody testing for previous exposure to Covid-19 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiogram Ejection Fraction | Measure of cardiac function | 6 months |
| High-sensitivity Cardiac Troponin Test | Cardiac Enzyme | 6 months |
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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.
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Children aged from 0 to 15 who are resident in the United Kingdom
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Waterfield, BMBCh | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Belfast Hospital for Sick Children | Belfast | BT126BA | United Kingdom | |||
| University Hospital of Wales |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33172887 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Healthy children of healthcare workers between 2 and 15 years of age | Posted | Mean | 95% Confidence Interval | Titres | 6 months |
|
|
All-cause mortality, serious and other adverse events were not monitored/assessed.
All-cause mortality, serious and other adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | All-cause mortality, serious and other adverse events were not monitored/assessed. |
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The limitations of this study are that all of the children in this study had only mild disease making comparison between severe and mild disease impossible. The children were also recruited from healthcare workers and the prevalence of antibodies is likely to be lower in the general population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Thomas Waterfield | Queen's University Belfast | 028 9024 5133 | t.waterfield@qub.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2022 | Jan 5, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| C000705967 | pediatric multisystem inflammatory disease, COVID-19 related |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000087124 | COVID-19 Serological Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma
| Blood Storage | Other | Storage of blood for multi-omics analysis |
|
| Brain Natriuretic Peptide | Cardiac enzyme | 6 months |
| Cardiff |
| United Kingdom |
| Royal Hospital for Children | Glasgow | United Kingdom |
| Public Health England | London | United Kingdom |
| Public Health England | Manchester | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Echocardiogram Ejection Fraction | Measure of cardiac function | Not Posted | Dec 2023 | 6 months | Participants |
| Secondary | High-sensitivity Cardiac Troponin Test | Cardiac Enzyme | Not Posted | Dec 2023 | 6 months | Participants |
| Secondary | Brain Natriuretic Peptide | Cardiac enzyme | Not Posted | Dec 2023 | 6 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D007239 |
| Infections |
| D012698 | Serologic Tests |
| D007159 | Immunologic Tests |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |