NCT04347408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

May 6, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

April 7, 2020

Results QC Date

August 10, 2021

Last Update Submit

November 14, 2023

Conditions

Keywords

antibodies

Outcome Measures

Primary Outcomes (1)

  • Immunoglobulins (G and M) to SARS-Cov2 in Plasma

    • Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays

    6 months

Secondary Outcomes (3)

  • Echocardiogram Ejection Fraction

    6 months

  • High-sensitivity Cardiac Troponin Test

    6 months

  • Brain Natriuretic Peptide

    6 months

Study Arms (3)

Healthy Children

Healthy children of healthcare workers between 2 and 15 years of age

Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)Other: Blood Storage

Paediatric Multisystem Inflammatory Syndrome

Children admitted to hospital with Paediatric Multisystem Inflammatory Syndrome

Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)Other: Blood Storage

Serious Infection

Children admitted to hospital with serious infections

Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)Other: Blood Storage

Interventions

Antibody testing for previous exposure to Covid-19

Healthy ChildrenPaediatric Multisystem Inflammatory SyndromeSerious Infection

Storage of blood for multi-omics analysis

Healthy ChildrenPaediatric Multisystem Inflammatory SyndromeSerious Infection

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal Belfast Hospital for Sick Children

Belfast, BT126BA, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Royal Hospital for Children

Glasgow, United Kingdom

Location

Public Health England

London, United Kingdom

Location

Public Health England

Manchester, United Kingdom

Location

Related Publications (1)

  • Waterfield T, Watson C, Moore R, Ferris K, Tonry C, Watt A, McGinn C, Foster S, Evans J, Lyttle MD, Ahmad S, Ladhani S, Corr M, McFetridge L, Mitchell H, Brown K, Amirthalingam G, Maney JA, Christie S. Seroprevalence of SARS-CoV-2 antibodies in children: a prospective multicentre cohort study. Arch Dis Child. 2021 Jul;106(7):680-686. doi: 10.1136/archdischild-2020-320558. Epub 2020 Nov 10.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Coronavirus Infectionspediatric multisystem inflammatory disease, COVID-19 related

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

COVID-19 TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSerologic TestsImmunologic TestsInvestigative TechniquesImmunologic Techniques

Limitations and 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.

Results Point of Contact

Title
Dr Thomas Waterfield
Organization
Queen's University Belfast

Study Officials

  • Thomas Waterfield, BMBCh

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator and Academic Clinical Lecturer

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 15, 2020

Study Start

May 6, 2020

Primary Completion

December 1, 2021

Study Completion

November 14, 2023

Last Updated

December 7, 2023

Results First Posted

August 18, 2021

Record last verified: 2023-11

Locations