NCT04898062

CRP-Apheresis for Attenuation of Pulmonary, MYocardial and/or Kidney Injury in COvid-19

Randomized, Controlled, Proof-Of-Concept Trial of CRP-Apheresis for Attenuation of Pulmonary MYocardial and/or Kidney Injury in COvid-19

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pentracor GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-invasive/invasive ventilation requirements compared to the control group. The influence of CRP-apheresis on the attenuation of pulmonary, myocardial and/or 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 patient's 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 and/or 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.

Conditions

• Covid19

Interventions

Type	Name	Description
DEVICE	CRP-apheresis	The major advantages of depleting C-reactive protein by therapeutic apheresis are the selective removal of the damaging agent by the highly specific ligand and the good controllability of the procedure, since the plasma can be passed over the column as often as necessary to achieve the desired reduction. In addition, treatment can be interrupted or discontinued at any time.

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2021-05-24
• Last updated: 2023-01-19

Locations

4 sites across 1 country: Germany