Seroprevalence of SARS-Cov-2 Antibodies in Children

November 14, 2023 updated by: Thomas Waterfield, Queen's University, Belfast

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT126BA
        • Royal Belfast Hospital for Sick Children
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Glasgow, United Kingdom
        • Royal Hospital for Children
      • London, United Kingdom
        • Public Health England
      • Manchester, United Kingdom
        • Public Health England

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 15 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children aged from 0 to 15 who are resident in the United Kingdom

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiogram Ejection Fraction
Time Frame: 6 months
Measure of cardiac function
6 months
High-sensitivity Cardiac Troponin Test
Time Frame: 6 months
Cardiac Enzyme
6 months
Brain Natriuretic Peptide
Time Frame: 6 months
Cardiac enzyme
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University, Belfast

Collaborators

Belfast Health and Social Care Trust

Investigators

  • Principal Investigator: Thomas Waterfield, BMBCh, Queen's University, Belfast

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2020

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282617

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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