Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311448
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Personalized Targeted Immunomodulation in COVID-19 ARDS
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Status:
COMPLETED
Status Verified Date:
2024-03
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:
COMODULATE
Brief Summary:
Rationale In COVID19 single-targeted immunomodulation mostly via an IL-6 receptor blocker was used by a one-size fits all non-targeted approach In future pandemics the same might occur However for individual patients this might not yield optimal treatment
Objectives This project aims to identify a way to individualize and target immunomodulation using COVID19 as a testcase for the future
Identify immunological pathways which are associated with outcome in C-ARDS
Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDSTocilizumab Anakinra etc
Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases
Study type Retrospective observational multicenter study in the Netherlands
Study population Adult patients 18 years hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome ARDS ie receiving invasive mechanical ventilation will be included
Intervention if applicable Not applicable retrospective study design
Nature and extent of the burden and risks associated with participation benefit and group relatedness Given the retrospective nature of the study no burden risks or benefits for the patient are associated with participation The target population of this study is specific to hospitalized patients with COVID-19
Objectives This project aims to identify a way to individualize and target immunomodulation using COVID19 as a testcase for the future
Identify immunological pathways which are associated with outcome in C-ARDS
Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDSTocilizumab Anakinra etc
Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases
Study type Retrospective observational multicenter study in the Netherlands
Study population Adult patients 18 years hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome ARDS ie receiving invasive mechanical ventilation will be included
Intervention if applicable Not applicable retrospective study design
Nature and extent of the burden and risks associated with participation benefit and group relatedness Given the retrospective nature of the study no burden risks or benefits for the patient are associated with participation The target population of this study is specific to hospitalized patients with COVID-19
Detailed Description:
None
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