Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761913
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2020-12-11
Brief Title:
Paediatric Inflammatory Multisystem Syndrome During COVID-19 Pandemic
Sponsor:
Anglia Ruskin University
Organization:
Anglia Ruskin University
Study Overview
Official Title:
Investigating Cytokine Storm Biomarkers in Children Presenting to Acute Paediatric Services Non-intensive Care With Paediatric Inflammatory Multisystem Syndrome During the Covid-19 Pandemic An Observation Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
During the COVID-19 pandemic a small minority of children have been presenting to acute paediatric services with a new syndrome Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 PIMS-TS Children with PIMS-TS present with symptoms of inflammation caused by the immune system going into overdrive - this is likely to be in response to the virus More severe cases involve inflammation and damage to the heart
The focus of this project is to identify children with milder forms of PIMS-TS who are at risk of progression to more severe disease Being able to predict the disease course of PIMS-TS at an early stage is important as it will allow clinicians to decide which patients should be treated with immunosuppressants which have been shown to reduce the severity of the illness but have side effects
Early data suggests that children with PIMS-TS have elevated biomarkers associated with an over-reaction of the bodys immune system also known as a cytokine storm reaction This study will explore whether children presenting with milder PIMS-TS have elevated cytokine storm blood profiles and whether these profiles differ between children who continue to have a mild disease course compared to those who develop severe disease
The focus of this project is to identify children with milder forms of PIMS-TS who are at risk of progression to more severe disease Being able to predict the disease course of PIMS-TS at an early stage is important as it will allow clinicians to decide which patients should be treated with immunosuppressants which have been shown to reduce the severity of the illness but have side effects
Early data suggests that children with PIMS-TS have elevated biomarkers associated with an over-reaction of the bodys immune system also known as a cytokine storm reaction This study will explore whether children presenting with milder PIMS-TS have elevated cytokine storm blood profiles and whether these profiles differ between children who continue to have a mild disease course compared to those who develop severe disease
Detailed Description:
During the COVID-19 pandemic a minority of children have presented to acute services with clinical features of a new syndrome known as Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 PIMS-TS This high inflammatory state likely triggered by the virus has overlapping features of Kawasakis and Toxic Shock Syndrome
The focus of this study is to identify which children presenting with mild PIMS-TS symptoms will go on to develop severe disease requiring intensive care unit ICU admission This is important as data suggests that early aggressive treatment with immunosuppression can lead to a relatively quick resolution in symptoms The results of this study could allow clinicians to be selective in treating patients in whom the benefits of treatment outweigh the risks
Early data suggests a cytokine storm is involved in the PIMS-TS disease process This proposed observational study will investigate whether children presenting to the non-ICU setting with features of PIMS-TS have raised cytokine storm biomarkers and whether these may be used to predict which children go onto develop severe disease
The proposed study will include up to 15 hospitals across East of England NHS clinical care teams will identify patients meeting the inclusion criteria and upload anonymised data into a secure web-based study database Data will be retrieved for retrospective cases from 1st March 2020 and prospective data entered up until September 2021
One hundred children presenting to acute non-ICU paediatric services with symptoms of PIMS-TS during the study period will be included
The primary objective of the study is to describe the cytokine storm biomarker profiles of children aged between 3 months to 16 years presenting with PIMS-TS to the non-ICU setting focussing on those biomarkers which are readily accessible to district general hospitals Pro-Beta Natriuretic peptide BNP ferritin and CRP
The secondary aims of the study are to
1 Compare cytokine storm biomarker profiles of children who have a mild disease course to those who develop severe disease to identify whether there are any differences between these groups
2 Evaluate the association between cytokine storm biomarker profiles and severe events
3 Compare i demographic characteristics including pre-existing disease and ii other routine clinical investigations of children who have a mild disease course and those who develop severe disease to identify any differences between these 2 groups
4 Evaluate the association between vaccination status and disease severity
5 Compare cytokine storm biomarker profiles of children testing positive and those testing negative for SARS-CoV-2 via PCR on 2x nasopharyngeal swabs to identify any differences between these 2 groups
The focus of this study is to identify which children presenting with mild PIMS-TS symptoms will go on to develop severe disease requiring intensive care unit ICU admission This is important as data suggests that early aggressive treatment with immunosuppression can lead to a relatively quick resolution in symptoms The results of this study could allow clinicians to be selective in treating patients in whom the benefits of treatment outweigh the risks
Early data suggests a cytokine storm is involved in the PIMS-TS disease process This proposed observational study will investigate whether children presenting to the non-ICU setting with features of PIMS-TS have raised cytokine storm biomarkers and whether these may be used to predict which children go onto develop severe disease
The proposed study will include up to 15 hospitals across East of England NHS clinical care teams will identify patients meeting the inclusion criteria and upload anonymised data into a secure web-based study database Data will be retrieved for retrospective cases from 1st March 2020 and prospective data entered up until September 2021
One hundred children presenting to acute non-ICU paediatric services with symptoms of PIMS-TS during the study period will be included
The primary objective of the study is to describe the cytokine storm biomarker profiles of children aged between 3 months to 16 years presenting with PIMS-TS to the non-ICU setting focussing on those biomarkers which are readily accessible to district general hospitals Pro-Beta Natriuretic peptide BNP ferritin and CRP
The secondary aims of the study are to
1 Compare cytokine storm biomarker profiles of children who have a mild disease course to those who develop severe disease to identify whether there are any differences between these groups
2 Evaluate the association between cytokine storm biomarker profiles and severe events
3 Compare i demographic characteristics including pre-existing disease and ii other routine clinical investigations of children who have a mild disease course and those who develop severe disease to identify any differences between these 2 groups
4 Evaluate the association between vaccination status and disease severity
5 Compare cytokine storm biomarker profiles of children testing positive and those testing negative for SARS-CoV-2 via PCR on 2x nasopharyngeal swabs to identify any differences between these 2 groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None