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Trial record 5 of 8 for:    CRP apheresis

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

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ClinicalTrials.gov Identifier: NCT04898062
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Pentracor GmbH

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-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.


Condition or disease Intervention/treatment Phase
Covid19 Device: CRP-apheresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Proof-Of-Concept Trial of CRP-Apheresis for Attenuation of Pulmonary MYocardial and/or Kidney Injury in COvid-19
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CRP-apheresis
Patients randomized to this group will undergo apheresis treatments with treatments every 24 ± 12 h each lasting 4-7 hours, until the CRP value does not rise to ≥ 30 mg/l within 96 h after the last treatment
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.
Other Name: CRP-depletion

No Intervention: Control
Patients randomized to this group will not undergo a apheresis treatments. They will be treated according to the current conventional treatment concept for covid-19 disease



Primary Outcome Measures :
  1. Necessity and duration of non-invasive/ invasive ventilation [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduced necessity and duration of non-invasive/ invasive ventilation is expected.


Secondary Outcome Measures :
  1. Length of intensive care unit stay [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a shorter intensive care unit stay is expected.

  2. Necessity of endotracheal intubation [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduced necessity of endotracheal intubation is expected.

  3. Reduction of lung injury [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduced lung injury as reflected by peripheral oxygen saturation, oxygen supplementation, Horovitz index, lung injury score is expected.

  4. Reduction of myocardial damage [ Time Frame: up to 10 days ]
    In the intervention group, a reduced myocardial damage as reflected by hs troponin, creatin kinase, creatin kinase MB fraction is expected.

  5. Reduction of kidney damage [ Time Frame: up to 10 days ]
    In the intervention group, a reduced kidney damage as reflected by creatinine, glomerular filtration rate, onset of dialysis, CKD stadium is expected.

  6. Improvement in general immune status [ Time Frame: up to 10 days ]
    In the intervention group, an improved general immune status as reflected by CRP, fibrinogen, leukocytes, thrombocytes and lactate dehydrogenase is expected.

  7. Cardiovascular, respiratory and renal SOFA score [ Time Frame: through study completion, an average of 14 days ]

    In the intervention group, improvements in cardiovascular, respiratory and renal SOFA scores are expected.

    *(Vincent JL: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. In:Intensive Care Med 1996:22;707-10.)


  8. Respiratory events [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduction of respiratory events (pulmonary embolism) is expected.

  9. Myocardial events [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduction of cardial events (cardiac arrhythmias, myocardial infarction, cardiopulmonary resuscitation, low cardiac output syndrome (LCOS), operation, percutaneous coronary intervention (PCI), angina pectoris) is expected.

  10. Renal events [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, a reduction of renal events (onset of dialysis requirement, deterioration of renal function (CKD increase) is expected.

  11. Safety of CRF apheresis [ Time Frame: through study completion, an average of 14 days ]
    In the intervention group, the absence of serious incidents is expected.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed SARS CoV-2 infection (PCR-test)
  • Oxygen therapy (maximum 'high-flow' therapy)
  • CRP plasma concentration ≥ 50 mg/l and/or
  • CRP increase ≥ 15 mg/l within 24 h 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)
  • Participation in other interventional trials
  • Extracorporeal membrane oxygenation (ECMO) support
  • Participation in other interventional trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898062


Contacts
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Contact: Matthias Thielmann, Prof. +49201 723 84908 matthias.thielmann@uk-essen.de
Contact: Wolfgang Ristau +494201 723 84927 wolfgang.ristau@uk-essen.de

Locations
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Germany
West-German Heart and Vascular Center, University Duisburg-Essen Recruiting
Essen, NRW, Germany, 45122
Contact: Matthias Thielmann, Prof.         
Gemeinschaftskrankenhaus Havelhöhe gGmbH Recruiting
Berlin, Germany, 14089
Contact: Fabrizio Esposito, Dr.    030 36501 414    fabrizio.esposito@havelhoehe.de   
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Germany, 66421
Contact: Philipp M. Lepper, Prof. Dr.    06841 1615052    philipp.lepper@uks.eu   
Klinikverbund Allgäu gGmbH Not yet recruiting
Kempten, Germany, 87439
Contact: Christian Schumann, Prof. Dr.    08323 910 8909    Pneumologie.Studien@klinikverbund-allgaeu.de   
Contact: Jan Torzewski, Prof. Dr.    0831 530 - 2217    jan.torzewski@kv-keoa.de   
Sponsors and Collaborators
Pentracor GmbH
Investigators
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Principal Investigator: Matthias Thielmann, Prof. West-German Heart and Vascular Center, University Duisburg-Essen
Publications:

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Responsible Party: Pentracor GmbH
ClinicalTrials.gov Identifier: NCT04898062    
Other Study ID Numbers: 21-10018-BO
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pentracor GmbH:
CRP-apheresis
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases