Blood Markers for Identifying & Investigating Infection With COVID19 & Sepsis in Children.

Covid19 Clinical Trial

— pSeP  

Official title:

Project Sepsis: Blood Markers Including Molecular and Cellular Profiling for Identifying and Investigating Severe CoronaVirus Disease 2019 and Sepsis in Children and Young People (pSEP/COVID-ChYP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904523
• Other study ID #: pSEP-COVID ChYP 263530
• Status: Recruiting
• Start date: December 16, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Cardiff University
• Contact: Peter Ghazal, PhD
• Phone: 07977099046
• Email: GhazalP[@]Cardiff.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.

Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit.

Using a systems approach towards mapping the body's immune and metabolic responses to COVID-19 or related illnesses and compare with other sepsis like illnesses.

Description:

Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.

Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit and wards using blood samples. Blood samples as small as a quarter of a teaspoon, will be collected only alongside other routine blood tests. By analysing the blood samples, we aim to identify unique signals of information from the child or young person's genetic code as well as other chemical markers. This is to map the body's immune and metabolic response to COVID-19 or related illness and compare with other illnesses like sepsis. It will help us better understand COVID-19 illness and its association with the abnormal inflammatory response. The research will not delay emergency treatment for children or young people. Appropriate procedures for consent such as deferred consent will be used in children or young people with serious illness. Young people of 16 and 17 years of age will be assessed for capacity to consent. The study results will not influence the clinical care of patients. The research would not be identifying any other genetic disorders. Even though the data obtained includes some unique genetic information, the research only uses anonymised details from patients and there is no risk to confidentiality. Remaining blood following analysis will be stored in Biobank for an agreed duration. Specific consent will be obtained from parents or legal guardians, or young people with capacity for analysis and collection of unique genetic data, clinical information, sample storage and use of anonymous but unique genetic data for other research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria: Children or young people< 18 years who are admitted to PCCU and who have an acute illness are eligible for participation in the study.

Children and young people from age 0 day to <18 years with confirmed COVID-19 illness and/or those who meet the Multisystem inflammatory syndrome case definition.

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Exclusion Criteria:

• Admitted to hospital for social reasons Or Declined consent by Parents or carers with legal responsibility or competent child Or Admitted to PCCU following a planned surgical procedure without an acute illness Or Direct clinical care team not able to provide research information in a language appropriate for non-English/Welsh speaking participants

Related Conditions & MeSH terms

• Covid19
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Diagnostic Test:Blood test
Drop of blood for RNA and metabolic analysis

Locations

Country	Name	City	State
United Kingdom	Cardiff University	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff University	Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome 1	To evaluate known blood molecular and genomic markers of infection in children and young persons with confirmed or probable COVID19 and compare with non COVID19 illnesses.	3 years
Secondary	Outcome 2	To investigate systemic pathway biology of SARS-CoV-2 infection and by comparison with other viral and bacterial sepsis cases identify new signatures associated with COVID-19 in patients up to 18 years of age.; To profile molecular analytes (proteins, lipids and nucleic acids) and blood cell phenotypes in children with sepsis	3 Years