Seroprevalence of SARS-Cov-2 Antibodies in Children

Sponsor
Queen's University, Belfast (Other)
Overall Status
Recruiting
CT.gov ID
NCT04347408
Collaborator
Belfast Health and Social Care Trust (Other)
1,100
5
54.9
220
4

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Immunoglobulins (G and M) to SARS-Cov2 in Plasma [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 [6 months]

    Measure of cardiac function

  2. High-sensitivity Cardiac Troponin Test [6 months]

    Cardiac Enzyme

  3. Brain Natriuretic Peptide [6 months]

    Cardiac enzyme

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Belfast Hospital for Sick Children Belfast United Kingdom BT126BA
2 University Hospital of Wales Cardiff United Kingdom
3 Royal Hospital for Children Glasgow United Kingdom
4 Public Health England London United Kingdom
5 Public Health England Manchester United Kingdom

Sponsors and Collaborators

  • Queen's University, Belfast
  • Belfast Health and Social Care Trust

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
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:
Apr 15, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Waterfield, Chief Investigator and Academic Clinical Lecturer, Queen's University, Belfast
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details In total, 1042 potential participants were screened for inclusion, of whom 50 were excluded; 18 were outside the specified age range, 1 met specific exclusion criteria,16 declined consent and 15 did not undergo phlebotomy. In total 992 were enrolled.
Pre-assignment Detail
Arm/Group Title Healthy Children
Arm/Group Description Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Period Title: Overall Study
STARTED 992
COMPLETED 992
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Healthy Children
Arm/Group Description Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Overall Participants 992
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
10.1
Sex: Female, Male (Count of Participants)
Female
483
48.7%
Male
509
51.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome
Title Immunoglobulins (G and M) to SARS-Cov2 in Plasma
Description • Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
Healthy children of healthcare workers between 2 and 15 years of age
Arm/Group Title Healthy Children
Arm/Group Description Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Measure Participants 992
Abbott SARS-CoV-2 IgG Assay (Index S/C)
4.86
Elecys Roche SARS-CoV-2 (Cut-Off-Index COI)
65.32
Diasorin Liason SARS-CoV-2 IgM (arbitrary units A/U)
64.17
2. Secondary Outcome
Title Echocardiogram Ejection Fraction
Description Measure of cardiac function
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
3. Secondary Outcome
Title High-sensitivity Cardiac Troponin Test
Description Cardiac Enzyme
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
4. Secondary Outcome
Title Brain Natriuretic Peptide
Description Cardiac enzyme
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame All-cause mortality, serious and other adverse events were not monitored/assessed.
Adverse Event Reporting Description All-cause mortality, serious and other adverse events were not monitored/assessed.
Arm/Group Title All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.
Arm/Group Description All-cause mortality, serious and other adverse events were not monitored/assessed.
All Cause Mortality
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Serious Adverse Events
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Other (Not Including Serious) Adverse Events
All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

The limitations of this study are that all of the children in this study had only mild disease making comparison between severe and mild disease impossible. The children were also recruited from healthcare workers and the prevalence of antibodies is likely to be lower in the general population.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr Thomas Waterfield
Organization Queen's University Belfast
Phone 028 9024 5133
Email t.waterfield@qub.ac.uk
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:
Apr 15, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Aug 1, 2021