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OpenTrials
Completed

NCT Number: NCT04347408

Seroprevalence of SARS-Cov-2 Antibodies in Children

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.

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Key information

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Belfast Hospital for Sick Children, Belfast, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Covid-19 Antibody testing (IgG and IgM)

Diagnostic Test

Antibody testing for previous exposure to Covid-19

Blood Storage

Other

Storage of blood for multi-omics analysis

Primary outcomes

  1. 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

Secondary outcomes

  1. Echocardiogram Ejection Fraction

    Time frame: 6 months

    Measure of cardiac function

  2. High-sensitivity Cardiac Troponin Test

    Time frame: 6 months

    Cardiac Enzyme

  3. Brain Natriuretic Peptide

    Time frame: 6 months

    Cardiac enzyme

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust

Registry information

Official study title

Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Apr 15, 2020
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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