Clinical Trials Directory

Trials / Completed

CompletedNCT04347408

Seroprevalence of SARS-Cov-2 Antibodies in Children

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,100 (actual)
Sponsor
Queen's University, Belfast · Academic / Other
Sex
All
Age
1 Month – 15 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCovid-19 Antibody testing (IgG and IgM)Antibody testing for previous exposure to Covid-19
OTHERBlood StorageStorage of blood for multi-omics analysis

Timeline

Start date
2020-05-06
Primary completion
2021-12-01
Completion
2023-11-14
First posted
2020-04-15
Last updated
2023-12-07
Results posted
2021-08-18

Locations

5 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04347408. Inclusion in this directory is not an endorsement.