Clinical trial NCT04347408: Seroprevalence of SARS-Cov-2 Antibodies in Children
Official title: Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Corona Virus Infection
Multisystem Inflammatory Syndrome in Children
Keywords: antibodies
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
First posted: 2020-04-15
Enrollment: 1100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 0 to 15 who are resident in the United Kingdom

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.

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.

Eligibility 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.

Primary outcomes:
measure: Immunoglobulins (G and M) to SARS-Cov2 in Plasma
timeFrame: 6 months
Secondary outcomes:
measure: Echocardiogram Ejection Fraction
timeFrame: 6 months
measure: High-sensitivity Cardiac Troponin Test
timeFrame: 6 months
measure: Brain Natriuretic Peptide
timeFrame: 6 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children
city: London
country: United Kingdom
facility: Public Health England
city: Manchester
country: United Kingdom
facility: Public Health England
Study officials:
affiliation: Queen's University, Belfast
name: Thomas Waterfield, BMBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.