Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898062
Status:
WITHDRAWN
Last Update Posted:
2023-01-19
First Post:
2021-05-20
Brief Title:
CRP-Apheresis for Attenuation of Pulmonary MYocardial andor Kidney Injury in COvid-19
Sponsor:
Pentracor GmbH
Organization:
Pentracor GmbH
Study Overview
Official Title:
Randomized Controlled Proof-Of-Concept Trial of CRP-Apheresis for Attenuation of Pulmonary MYocardial andor Kidney Injury in COvid-19
Status:
WITHDRAWN
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient recruitment of study patients based on the existing inclusion and exclusion criteria is not possible within a reasonable period of time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPMYKCO
Brief Summary:
The CAPMYKCO study is a randomized controlled open-label single center proof of concept trial The aim of this study is to evaluate whether a CRP-apheresis in addition to the current standard therapy is intended to mitigate the severity of the disease course of SARS-CoV-2 especially with regard to tissue injury in the lungs heart and kidneys and their consequences
CRP-apheresis should reduce the necessity and duration of non-invasiveinvasive ventilation requirements compared to the control group
The influence of CRP-apheresis on the attenuation of pulmonary myocardial andor kidney tissue injury as well as the course of the COVID-19 disease will also be demonstrated by evaluating various biomarkers several clinical scoring systems and the duration of intensive care medical treatment
CRP-apheresis should reduce the necessity and duration of non-invasiveinvasive ventilation requirements compared to the control group
The influence of CRP-apheresis on the attenuation of pulmonary myocardial andor kidney tissue injury as well as the course of the COVID-19 disease will also be demonstrated by evaluating various biomarkers several clinical scoring systems and the duration of intensive care medical treatment
Detailed Description:
The prognostic value of C-reactive protein CRP in assessing disease progression in COVID-19 is well known The steeper the CRP rise in the days after infection and the higher the CRP concentration at hospitalization the worse the prognosis It is believed that CRP concentration not only reflects tissue damage but also causally contributes to the severity of the damage that occurs CRP apheresis effectively limits CRP rise which may lead to improved prognosis CRP apheresis is a therapeutic hemapheresis procedure that selectively removes C-reactive protein from the patients plasma Other causal therapies for immediate selective reduction of CRP in the acute phase of disease are not currently available
In the planned CAPMYKCO study CRP-apheresis in addition to current standard COVID-19 therapy is expected to mitigate the severity of disease progression particularly with regard to tissue injury in the lungs the heart andor the kidneys and their respective clinical consequences
CRP-apheresis treatment in COVID-19 patients should reduce the necessity and duration of non-invasive invasive ventilation compared to the control group
The influence of CRP-apheresis on the course of the COVID-19 disease will also be demonstrated by evaluating different organ biomarkers and the duration of intensive medical treatment
In the planned CAPMYKCO study CRP-apheresis in addition to current standard COVID-19 therapy is expected to mitigate the severity of disease progression particularly with regard to tissue injury in the lungs the heart andor the kidneys and their respective clinical consequences
CRP-apheresis treatment in COVID-19 patients should reduce the necessity and duration of non-invasive invasive ventilation compared to the control group
The influence of CRP-apheresis on the course of the COVID-19 disease will also be demonstrated by evaluating different organ biomarkers and the duration of intensive medical treatment
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