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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    50
  • sponsor
    University Hospital, Essen
Updated on 4 June 2021

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 for endotracheal intubation and mechanical ventilation as well as the 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.

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 for endotracheal intubation and the 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.

Details
Condition COVID19
Treatment CRP-apheresis
Clinical Study IdentifierNCT04898062
SponsorUniversity Hospital, Essen
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Confirmed SARS CoV-2 infection (PCR-test)
Oxygen therapy (maximum 'high-flow' therapy)
CRP plasma concentration 25 mg/l
CRP increase 15mg/l within 48h after admission
Completed informed consent and written informed consent
Legal capacity

Exclusion Criteria

Age < 18 years
Pregnancy / lactation period
Invasive, mechanical ventilation
Extracorporeal membrane oxygenation (ECMO) support
Participation in other interventional trials
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