Seroprevalence of SARS-Cov-2 Antibodies in Children

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347408
• Other study ID #: 282617
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: November 14, 2023

Study information

• Verified date: November 2023
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: November 14, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Multisystem Inflammatory Syndrome in Children

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Royal Hospital for Children	Glasgow
United Kingdom	Public Health England	London
United Kingdom	Public Health England	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Echocardiogram Ejection Fraction	Measure of cardiac function	6 months
Secondary	High-sensitivity Cardiac Troponin Test	Cardiac Enzyme	6 months
Secondary	Brain Natriuretic Peptide	Cardiac enzyme	6 months