An observational study in COVID, Corona Virus Infection and Multisystem Inflammatory Syndrome in Children, sponsored by Queen's University, Belfast. Completed at 5 sites in United Kingdom. Open to participants aged 1 Month to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Queen's University, Belfast · Observational
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 1,100 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged from 0 to 15 who are resident in the United Kingdom
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.
Healthy children of healthcare workers between 2 and 15 years of age
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM) · Other: Blood Storage
Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM) · Other: Blood Storage
Children admitted to hospital with serious infections
Diagnostic Test: Covid-19 Antibody testing (IgG and IgM) · Other: Blood Storage
Antibody testing for previous exposure to Covid-19
Storage of blood for multi-omics analysis
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
Time frame: 6 months
Echocardiogram Ejection Fraction
Measure of cardiac function
Time frame: 6 months
High-sensitivity Cardiac Troponin Test
Cardiac Enzyme
Time frame: 6 months
Brain Natriuretic Peptide
Cardiac enzyme
Time frame: 6 months
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.
| Milestone | Healthy Children |
|---|---|
| Started | 992 |
| Completed | 992 |
| Not completed | 0 |
• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
| Titres | Healthy Children |
|---|---|
| Abbott SARS-CoV-2 IgG Assay (Index S/C) | 4.86 (4.28 to 5.45) |
| Elecys Roche SARS-CoV-2 (Cut-Off-Index COI) | 65.32 (43.24 to 87.40) |
| Diasorin Liason SARS-CoV-2 IgM (arbitrary units A/U) | 64.17 (37.99 to 90.36) |
Measure of cardiac function
Results for this outcome have not been posted.
Cardiac Enzyme
Results for this outcome have not been posted.
Cardiac enzyme
Results for this outcome have not been posted.
Collected over All-cause mortality, serious and other adverse events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed. | — | — | — |
| Age, Continuous(years) | Healthy Children |
|---|---|
| Median | 10.1 (2.03 to 15.99) |
| Sex: Female, Male(Participants) | Healthy Children |
|---|---|
| Female | 483 |
| Male | 509 |
| Race and Ethnicity Not Collected(Participants) | Healthy Children |
|---|
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Queen's University, Belfast