Seroprevalence of SARS-Cov-2 Antibodies in Children
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Healthy Children Healthy children of healthcare workers between 2 and 15 years of age |
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Other: Blood Storage
Storage of blood for multi-omics analysis
|
Paediatric Multisystem Inflammatory Syndrome Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome |
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Other: Blood Storage
Storage of blood for multi-omics analysis
|
Serious Infection Children admitted to hospital with serious infections |
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)
Antibody testing for previous exposure to Covid-19
Other: Blood Storage
Storage of blood for multi-omics analysis
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Royal Belfast Hospital for Sick Children | Belfast | United Kingdom | BT126BA | |
2 | University Hospital of Wales | Cardiff | United Kingdom | ||
3 | Royal Hospital for Children | Glasgow | United Kingdom | ||
4 | Public Health England | London | United Kingdom | ||
5 | Public Health England | Manchester | United Kingdom |
Sponsors and Collaborators
- Queen's University, Belfast
- Belfast Health and Social Care Trust
Investigators
- Principal Investigator: Thomas Waterfield, BMBCh, Queen's University, Belfast
Study Documents (Full-Text)
More Information
Publications
None provided.- 282617
Study Results
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. |
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Pre-assignment Detail |
Arm/Group Title | Healthy Children |
---|---|
Arm/Group Description | 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 |
Period Title: Overall Study | |
STARTED | 992 |
COMPLETED | 992 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Healthy Children |
---|---|
Arm/Group Description | 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 |
Overall Participants | 992 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
10.1
|
Sex: Female, Male (Count of Participants) | |
Female |
483
48.7%
|
Male |
509
51.3%
|
Race and Ethnicity Not Collected (Count of Participants) |
Outcome Measures
Title | Immunoglobulins (G and M) to SARS-Cov2 in Plasma |
---|---|
Description | • Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
Healthy children of healthcare workers between 2 and 15 years of age |
Arm/Group Title | Healthy Children |
---|---|
Arm/Group Description | 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 |
Measure Participants | 992 |
Abbott SARS-CoV-2 IgG Assay (Index S/C) |
4.86
|
Elecys Roche SARS-CoV-2 (Cut-Off-Index COI) |
65.32
|
Diasorin Liason SARS-CoV-2 IgM (arbitrary units A/U) |
64.17
|
Title | Echocardiogram Ejection Fraction |
---|---|
Description | Measure of cardiac function |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | High-sensitivity Cardiac Troponin Test |
---|---|
Description | Cardiac Enzyme |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Brain Natriuretic Peptide |
---|---|
Description | Cardiac enzyme |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | All-cause mortality, serious and other adverse events were not monitored/assessed. | |
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Adverse Event Reporting Description | All-cause mortality, serious and other adverse events were not monitored/assessed. | |
Arm/Group Title | All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | |
Arm/Group Description | All-cause mortality, serious and other adverse events were not monitored/assessed. | |
All Cause Mortality |
||
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Serious Adverse Events |
||
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr Thomas Waterfield |
---|---|
Organization | Queen's University Belfast |
Phone | 028 9024 5133 |
t.waterfield@qub.ac.uk |
- 282617