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

Pentracor

Status: Withdrawn

Conditions: Covid19

Treatments: Device: CRP-apheresis

Study type: Interventional

Funder types: Industry

Identifiers

NCT04898062

21-10018-BO

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CRP-apheresis

Active Comparator group

Description:

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

Treatment:

Device: CRP-apheresis

Control

No Intervention group

Description:

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