Covid19 Clinical Trial
— pSePOfficial 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)
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.
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. - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cardiff University | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Cardiff University | Cardiff and Vale University Health Board |
United Kingdom,
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 |
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