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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 : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Matthias Thielmann, University Hospital, Essen

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 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.


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 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.

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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 : June 30, 2022
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Active Comparator: CRP-apheresis
Patients randomized to this group will undergo 4 apheresis treatments, each lasting 4-7 hours.
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. Duration of non-invasive/ invasive ventilation [days, hrs] [ Time Frame: 14 days ]
    In the intervention group, a reduced duration of non-invasive/ invasive ventilation is expected.

  2. Necessity for endotracheal intubation [ Time Frame: 14 days ]
    In the intervention group, a reduced rate of endotracheal intubation is expected.


Secondary Outcome Measures :
  1. Reduction of pulmonary injury [ Time Frame: 14 days ]

    Tissue injury of the lungs:

    • Lung injury score*: scores >=3 (≥2.5 if rapid deterioration) are part of the criteria used in the referral to extracorporeal membrane oxygenation in acute lung injury. Another interpretation of the score indicates that: ≥2.5 - severe lung injury or ARDS (acute respiratory distress syndrome).
    • Horovitz-index [PaO2/FiO2]
    • Neopterin (serum concentration) [ng/mL]
    • Oxygen saturation [sO2%]
    • Necessity for mechanical ventilation [y/n] *(JF Murray et al. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis;1988:138:720-3.)

  2. Reduction of myocardial injury [ Time Frame: 14 days ]

    Tissue injury of the heart:

    • hs-Troponin I (serum concentration) [ng/mL] and its log area under curve (AUC) within 14 days
    • Creatine kinase (serum concentration) [U/L]
    • CK-MB fraction (CK-MB) (serum concentration) [U/L]

  3. Reduction of kidney injury [ Time Frame: 14 days ]

    Tissue injury of the kidneys:

    • Incidence of acute kidney injury (AKI) (defined by: RIFLE, KDIGO, AKIN criteria) [y/n]
    • Creatinine (serum concentration) [mg/dL] [μmol/L]
    • Albumine (serum concentration) [mg/dL]
    • Estimated Glomerular filtration rate (eGFR) [mL/min/1.73 qm]
    • Nephro-check (urine concentration) TIMP-2 (tissue inhibitor of metalloproteinase-2) [mg/L] and IGFBP-7 (insulin-like growth factor-binding protein 7) [mg/L]
    • Proenkephalin (serum concentration) [pmol/L]
    • Necessity for renal replacement therapy (RRT) within 14 days [y/n]

  4. Reduction of other tissue injury [ Time Frame: 14 days ]

    Immune status and other tissue injury:

    • C-reactive protein (CRP) [mg/L]
    • Interleukin-6 (IL-6) [pg/mL]
    • D-dimer [µg/mL]
    • Ferritin [µg/L]
    • Leukocytes [/nL]
    • Lactate dehydrogenase (LDH) [U/L]

  5. Length of intensive care unit stay [ Time Frame: Until hospital discharge assessed up to 14 days ]
    In the intervention group, a shorter stay at the ICU is expected [days, hrs]

  6. SOFA-score (Sequential Organ Failure Assessment) score [ Time Frame: 14 days ]

    The Sequential Organ Failure Assessment score* ranges from 0 to +4 [0, +1, +2, +3, +4] with an increasing risk of death or prolonged intensive care unit stay.

    *(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.)


  7. Incidence of expected and unexpected adverse effects of CRP-apheresis. [ Time Frame: 14 days ]

    In the intervention group, the absence of unexpected serious adverse effects is expected.

    Serious adverse events [y/n]




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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 ≥ 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

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.         
Sponsors and Collaborators
University Hospital, Essen
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: Matthias Thielmann, Prof. Dr. med., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04898062    
Other Study ID Numbers: 21-10018-BO
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: May 28, 2021
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 Matthias Thielmann, University Hospital, Essen:
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