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

January 17, 2023 updated by: Pentracor GmbH

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14089
        • Gemeinschaftskrankenhaus Havelhöhe gGmbH
      • Homburg, Germany, 66421
        • Universitatsklinikum des Saarlandes
      • Kempten, Germany, 87439
        • Klinikverbund Allgäu gGmbH
    • NRW
      • Essen, NRW, Germany, 45122
        • West-German Heart and Vascular Center, University Duisburg-Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 14 days
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.
through study completion, an average of 14 days
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.
through study completion, an average of 14 days
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.
up to 10 days
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.
up to 10 days
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.
up to 10 days
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.)
through study completion, an average of 14 days
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.
through study completion, an average of 14 days
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.
through study completion, an average of 14 days
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.
through study completion, an average of 14 days
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.
through study completion, an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pentracor GmbH

Investigators

  • Principal Investigator: Matthias Thielmann, Prof., West-German Heart and Vascular Center, University Duisburg-Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-10018-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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