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

NCT04898062 | Withdrawn DMC

• 1 other identifier: 21-10018-BO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Keywords

CRP-apheresis; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Necessity and duration of non-invasive/ invasive ventilation

  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 Outcomes (11)

• Length of intensive care unit stay

  through study completion, an average of 14 days

• Necessity of endotracheal intubation

  through study completion, an average of 14 days

• Reduction of lung injury

  through study completion, an average of 14 days

• Reduction of myocardial damage

  up to 10 days

• Reduction of kidney damage

  up to 10 days

Study Arms (2)

CRP-apheresis

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

CRP-apheresis DEVICE

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.

Also known as: CRP-depletion

CRP-apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pentracor GmbH: lead

Study Sites (4)

West-German Heart and Vascular Center, University Duisburg-Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Gemeinschaftskrankenhaus Havelhöhe gGmbH

Berlin, 14089, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Klinikverbund Allgäu gGmbH

Kempten, 87439, Germany

Location

Related Publications (10)

• Mueller AA, Tamura T, Crowley CP, DeGrado JR, Haider H, Jezmir JL, Keras G, Penn EH, Massaro AF, Kim EY. Inflammatory Biomarker Trends Predict Respiratory Decline in COVID-19 Patients. Cell Rep Med. 2020 Nov 17;1(8):100144. doi: 10.1016/j.xcrm.2020.100144. Epub 2020 Oct 29.

  PMID: 33163981 BACKGROUND

• Smilowitz NR, Kunichoff D, Garshick M, Shah B, Pillinger M, Hochman JS, Berger JS. C-reactive protein and clinical outcomes in patients with COVID-19. Eur Heart J. 2021 Jun 14;42(23):2270-2279. doi: 10.1093/eurheartj/ehaa1103.

  PMID: 33448289 BACKGROUND

• Kunze R. C-Reactive Protein: From Biomarker to Trigger of Cell Death? Ther Apher Dial. 2019 Dec;23(6):494-496. doi: 10.1111/1744-9987.12802. No abstract available.

  PMID: 31788974 BACKGROUND

• Torzewski J, Heigl F, Zimmermann O, Wagner F, Schumann C, Hettich R, Bock C, Kayser S, Sheriff A. First-in-Man: Case Report of Selective C-Reactive Protein Apheresis in a Patient with SARS-CoV-2 Infection. Am J Case Rep. 2020 Jul 14;21:e925020. doi: 10.12659/AJCR.925020.

  PMID: 32661220 BACKGROUND

• Pepys MB. C-reactive protein predicts outcome in COVID-19: is it also a therapeutic target? Eur Heart J. 2021 Jun 14;42(23):2280-2283. doi: 10.1093/eurheartj/ehab169. No abstract available.

  PMID: 33778886 BACKGROUND

• Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available.

  PMID: 3202424 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. 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. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Ringel J, Ramlow A, Bock C, Sheriff A. Case Report: C-Reactive Protein Apheresis in a Patient With COVID-19 and Fulminant CRP Increase. Front Immunol. 2021 Aug 2;12:708101. doi: 10.3389/fimmu.2021.708101. eCollection 2021.

  PMID: 34408751 BACKGROUND

• Torzewski J, Zimmermann O, Kayser S, Heigl F, Wagner F, Sheriff A, Schumann C. Successful Treatment of a 39-Year-Old COVID-19 Patient with Respiratory Failure by Selective C-Reactive Protein Apheresis. Am J Case Rep. 2021 Aug 5;22:e932964. doi: 10.12659/AJCR.932964.

  PMID: 34351878 BACKGROUND

• Schumann C, Heigl F, Rohrbach IJ, Sheriff A, Wagner L, Wagner F, Torzewski J. A Report on the First 7 Sequential Patients Treated Within the C-Reactive Protein Apheresis in COVID (CACOV) Registry. Am J Case Rep. 2022 Jan 10;23:e935263. doi: 10.12659/AJCR.935263.

  PMID: 35007274 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthias Thielmann, Prof.

  West-German Heart and Vascular Center, University Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 24, 2021
• Study Start: May 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: January 19, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)