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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04347408|
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : March 10, 2021
|Condition or disease||Intervention/treatment|
|COVID Corona Virus Infection||Diagnostic Test: Covid-19 Antibody testing (IgG and IgM)|
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.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|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 13, 2020|
|Actual Study Completion Date :||December 13, 2020|
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
- Immunoglobulins (G and M) to SARS-Cov2 in plasma [ Time Frame: 6 months ]
Biospecimen Retention: Samples Without DNA
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
|Royal Belfast Hospital for Sick Children|
|Belfast, United Kingdom, BT126BA|
|University Hospital of Wales|
|Cardiff, United Kingdom|
|Royal Hospital for Children|
|Glasgow, United Kingdom|
|Public Health England|
|London, United Kingdom|
|Public Health England|
|Manchester, United Kingdom|
|Principal Investigator:||Thomas Waterfield, BMBCh||Queen's University, Belfast|