Seroprevalence of SARS-Cov-2 Antibodies in Children
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ClinicalTrials.gov Identifier: NCT04347408 |
Recruitment Status :
Recruiting
First Posted : April 15, 2020
Results First Posted : August 18, 2021
Last Update Posted : January 11, 2022
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Condition or disease | Intervention/treatment |
---|---|
COVID Corona Virus Infection Multisystem Inflammatory Syndrome in Children | Diagnostic Test: Covid-19 Antibody testing (IgG and IgM) Other: Blood Storage |
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 Type : | Observational |
Estimated Enrollment : | 1100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study |
Actual Study Start Date : | May 6, 2020 |
Actual Primary Completion Date : | December 1, 2021 |
Estimated Study Completion Date : | December 1, 2024 |

Group/Cohort | Intervention/treatment |
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Healthy Children
Healthy children of healthcare workers between 2 and 15 years of age
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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
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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
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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 |
- Immunoglobulins (G and M) to SARS-Cov2 in Plasma [ Time Frame: 6 months ]• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
- Echocardiogram Ejection Fraction [ Time Frame: 6 months ]Measure of cardiac function
- High-sensitivity Cardiac Troponin Test [ Time Frame: 6 months ]Cardiac Enzyme
- Brain Natriuretic Peptide [ Time Frame: 6 months ]Cardiac enzyme
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 1 Month to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347408
Contact: Thomas Waterfield, BMBCh | 07872990521 | t.waterfield@qub.ac.uk | |
Contact: Sharon Christie, PhD | 07899913551 | sharon.christie@belfasttrust.hscni.net |
United Kingdom | |
Royal Belfast Hospital for Sick Children | Recruiting |
Belfast, United Kingdom, BT126BA | |
Contact: Thomas Waterfield, BMBCh 07872990521 t.waterfield@qub.ac.uk | |
Contact: Sharon Christie, PhD 07899913551 sharon-christie@belfasttrust.hscni.net | |
University Hospital of Wales | Completed |
Cardiff, United Kingdom | |
Royal Hospital for Children | Completed |
Glasgow, United Kingdom | |
Public Health England | Completed |
London, United Kingdom | |
Public Health England | Completed |
Manchester, United Kingdom |
Principal Investigator: | Thomas Waterfield, BMBCh | Queen's University, Belfast |
Documents provided by Thomas Waterfield, Queen's University, Belfast:
Responsible Party: | Thomas Waterfield, Chief Investigator and Academic Clinical Lecturer, Queen's University, Belfast |
ClinicalTrials.gov Identifier: | NCT04347408 |
Other Study ID Numbers: |
282617 |
First Posted: | April 15, 2020 Key Record Dates |
Results First Posted: | August 18, 2021 |
Last Update Posted: | January 11, 2022 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
antibodies |
Coronavirus Infections Virus Diseases Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Antibodies Immunologic Factors Physiological Effects of Drugs |