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Seroprevalence of SARS-Cov-2 Antibodies in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347408
Recruitment Status : Recruiting
First Posted : April 15, 2020
Results First Posted : August 18, 2021
Last Update Posted : January 11, 2022
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 Multisystem Inflammatory Syndrome in Children Diagnostic Test: Covid-19 Antibody testing (IgG and IgM) Other: Blood Storage

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.

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Study Type : Observational
Estimated Enrollment : 1100 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 1, 2021
Estimated Study Completion Date : December 1, 2024

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.


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


Contacts
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Contact: Thomas Waterfield, BMBCh 07872990521 t.waterfield@qub.ac.uk
Contact: Sharon Christie, PhD 07899913551 sharon.christie@belfasttrust.hscni.net

Locations
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United Kingdom
Royal Belfast Hospital for Sick Children Recruiting
Belfast, United Kingdom, BT126BA
Contact: Thomas Waterfield, BMBCh    07872990521    t.waterfield@qub.ac.uk   
Contact: Sharon Christie, PhD    07899913551    sharon-christie@belfasttrust.hscni.net   
University Hospital of Wales Completed
Cardiff, United Kingdom
Royal Hospital for Children Completed
Glasgow, United Kingdom
Public Health England Completed
London, United Kingdom
Public Health England Completed
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
  Study Documents (Full-Text)

Documents provided by Thomas Waterfield, Queen's University, Belfast:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Results First Posted: August 18, 2021
Last Update Posted: January 11, 2022
Last Verified: August 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
Virus Diseases
Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs