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Seroprevalence of SARS-Cov-2 Antibodies in Children

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ClinicalTrials.gov Identifier: NCT04347408
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Thomas Waterfield, Queen's University, Belfast

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.

Condition or disease Intervention/treatment
COVID Corona Virus Infection Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)

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.

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Study Type : Observational
Actual Enrollment : 1000 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 13, 2020
Actual Study Completion Date : December 13, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Immunoglobulins (G and M) to SARS-Cov2 in plasma [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy children aged from 0 to 15 who are resident in the United Kingdom
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.


Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom, BT126BA
University Hospital of Wales
Cardiff, United Kingdom
Royal Hospital for Children
Glasgow, United Kingdom
Public Health England
London, United Kingdom
Public Health England
Manchester, United Kingdom
Sponsors and Collaborators
Queen's University, Belfast
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: Thomas Waterfield, BMBCh Queen's University, Belfast
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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
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Waterfield, Queen's University, Belfast:
antibodies
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs