Blood Markers for Identifying & Investigating Infection With COVID19 & Sepsis in Children.
pSeP
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)
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2020
CompletedFirst Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMay 27, 2021
May 1, 2021
2.5 years
May 26, 2021
May 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Outcome 2
3 Years
Study Arms (2)
Cases
Cases: 1\. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department.
Controls
Controls: 1. Children proven to have a non COVID infectious illness on laboratory testing. 2. Children with sepsis or septic shock due to non-COVID infectious illness. 3. Children or young people admitted to PCCU following accidental trauma.
Interventions
Eligibility Criteria
Cases: 1\. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department. Controls: 1. Children proven to have a non COVID infectious illness on laboratory testing. 2. Children with sepsis or septic shock due to non-COVID infectious illness. 3. Children or young people admitted to PCCU following accidental trauma.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff Universitylead
- Cardiff and Vale University Health Boardcollaborator
Study Sites (1)
Cardiff University
Cardiff, CF 14 4XN, United Kingdom
Related Publications (1)
Oruganti S, Rodrigues PRS, White D, Watkins WJ, Shapey S, Barrow A, Al Samsam R, Ali S, Gajraj M, Skone R, Jardine M, Evans J, Struik S, Song JE, Abood L, Paquete B, Foulkes S, Saunders B, Strang A, Kotecha SJ, Phillips B, Evans A, Buchanan I, Bowes S, Ali B, Gore M, Thomas-Turner R, Andrews R, Zaher S, Sharma S, Chakraborty M, Parkinson E, Liberatore F, Woolley T, Edkins S, Davies LC, Moet L, McLaren JE, Watson GL, O'Donnell V, Hood K, Ghazal P. Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study. BMJ Open. 2023 Mar 27;13(3):e067002. doi: 10.1136/bmjopen-2022-067002.
PMID: 36972964DERIVED
Biospecimen
Whole blood samples will be collected, processed and RNA may be stored.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2021
First Posted
May 27, 2021
Study Start
December 16, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
May 27, 2021
Record last verified: 2021-05