Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04478539
Status:
COMPLETED
Last Update Posted:
2022-12-01
First Post:
2020-07-14
Brief Title:
Extracorporeal Blood Purification as a Treatment Modality for COVID-19
Sponsor:
Zan Mitrev Clinic
Organization:
Zan Mitrev Clinic
Study Overview
Official Title:
Clinical Efficacy and Safety of Extracorporeal Blood Purification to Control Hyperinflammation and Hypercoagulability in COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Several studies have suggested a potential clinical benefit of controlling hyper inflammation triggered by SARS-CoV-2COVID-19 Blood purification the removal of excessive proinflammatory mediators may control disease progression and support clinical recovery
For this purpose COVID-19 patients might benefit from treatment with AN69ST hemofilter based extracorporeal blood purification
For this purpose COVID-19 patients might benefit from treatment with AN69ST hemofilter based extracorporeal blood purification
Detailed Description:
COVID-19 disease progression is associated with dysregulated immunity commonly referred to as cytokine storm in particular aberrant Interleukin IL 6 levels that promote numerous pathological downstream effects Hyperinflammation is a well-established trigger of multiorgan failure for example acute kidney injury Moreover recent reports point to a link between hyper inflammation and COVID-19 induced coagulopathy as a result of increased production of clotting factors by the liver
Despite several lines of evidence pointing to a potential clinical benefit of controlling hyperinflammation triggered by COVID-19 management of COVID-19 remains mostly supportive built around continuous respiratory support
To this end considering the underlying immunological character of COVID-19 disease and the high risk of SARS-CoV-2 hyperinflammation to trigger ARDS hypercoagulability and Acute Kidney Injury AKI this study aims to monitor selected biochemical immunological and coagulation parameters in combination with radiological imaging to guide clinical practice and to tailor therapy consisting of 1 early initiation of blood purification using the oXiris AN69ST filter 2 systemic heparinisation and 3 respiratory support
Despite several lines of evidence pointing to a potential clinical benefit of controlling hyperinflammation triggered by COVID-19 management of COVID-19 remains mostly supportive built around continuous respiratory support
To this end considering the underlying immunological character of COVID-19 disease and the high risk of SARS-CoV-2 hyperinflammation to trigger ARDS hypercoagulability and Acute Kidney Injury AKI this study aims to monitor selected biochemical immunological and coagulation parameters in combination with radiological imaging to guide clinical practice and to tailor therapy consisting of 1 early initiation of blood purification using the oXiris AN69ST filter 2 systemic heparinisation and 3 respiratory support
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None