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COVID-19 & CytoSorb Therapy

Initial reports suggest that COVID-19 is associated with severe disease, that requires intensive care in approximately 5% of proven infections. The virus can result in a dysregulated immune response and this cytokine storm seems to be associated with disease severity, as it can lead to capillary leak syndrome, progressive lung injury, respiratory failure and acute respiratory distress syndrome (ARDS).

In addition to ARDS, further complications in the critically ill include shock, acute cardiac injury and AKI. This is in line with what is known from other viral infections like influenza and previous coronavirus infections (SARS, MERS), as well as with the general fact that infectious and non-infectious triggers can result in a cytokine storm, progressing to vasoplegic shock and finally multi organ dysfunction syndrome.

Rationale of using CytoSorb Therapy in critically ill COVID-19 patients

CytoSorb is a European Union-approved extracorporeal cytokine adsorber, designed to broadly reduce cytokine storm and other inflammatory mediators in the blood that could otherwise lead to uncontrolled systemic inflammation, organ failure, and death in many life-threatening illnesses. CytoSorb has been used safely in more than 100,000 treatments worldwide, primarily in the treatment of systemic hyperinflammation in a wide variety of life-threatening conditions.

On 10 April 2020 the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) (*) for emergency use of CytoSorb to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure by reducing pro-inflammatory cytokine levels, which may ameliorate a cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit to such patients.

Experience in Treating Patients with COVID-19 infection

The rationale of using blood purification to treat cytokine storm in critically-ill COVID-19 patients was recently detailed by a recent publication that concluded, “Finally, a sepsis-like syndrome might occur frequently due to the virus itself or to a superimposed bacterial infection and in this case, since pharmacological approaches have shown poor results, new extracorporeal organ support therapies including hemoadsorption and hemoperfusion, with new sorbent cartridges designed to remove cytokines and other circulating mediators, should be considered.” (1)

To date, more than 2,800 critically ill patients with COVID-19 infection have been treated with CytoSorb in 30 countries. Although patient level data is not yet available due to the extraordinary circumstances in these countries, the positive results in Italy have led to the formal recommendation by the Italy Brescia Renal COVID Task Force and published by the Italian Society of Nephrology and ERA-EDTA, to specifically use CytoSorb in severe COVID-19 patients with Stage 3 AKI receiving Continuous Renal Replacement Therapy (CRRT). (2) Also, the recent National Guidelines on adult COVID-19 patients from Panama recommend CytoSorb Therapy, as well as a recently published expert consensus from Colombia. (3,4) In addition, the recent Handbook of COVID-19 Prevention and Treatment from Zhejiang University School of Medicine, China, is also recommending blood purification to treat cytokine storm in critical cases of COVID-19 infection. (5,6) Previously published data indicate a rapid and sustained reduction of IL-6 levels, as well as an improvement in oxygenation and hemodynamics. (7,8,9)

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Rationale of use

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CLINICAL ACTIVITIES in
COVID-19 patients

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WHO has assigned a temporary diagnoses code for COVID-19...

LITERATURE

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WHO has assigned a temporary diagnoses code for COVID-19...

CODING OF COVID-19 PATIENTS

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WHO has assigned a temporary diagnoses code for COVID-19...

Guidelines & Links

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COVID-19 treatment guidelines recommending CytoSorb Therapy​

Webinars

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Press Releases

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Options for actions &
Rationale of use

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CLINICAL ACTIVITIES in COVID-19 patients

At CytoSorbents, we are continuously working to build and expand the knowledge surrounding CytoSorb therapy, also in patients with COVID-19. Here we provide an overview of the main clinical activities tailored to generate unbiased scientific evidence.

CytoSorbents conducts its own studies – but since the CytoSorb therapy has been CE approved clinicians have as well been investigating effects of the therapy in investigator-initiated studies. These studies are completely independent from CytoSorbents.

Studies initiated by CytoSorbents:

Title
Study type
Primary Outcome Measure
Link
Registry of CytoSorb Therapy in COVID-19 ICU Patients
Prospective observational study (patient registry)
ICU mortality
ClinicalTrials.gov

Selected investigator-initiated studies and registries (initiated and run independently from CytoSorbents) that include or focus on CytoSorb treatment in COVID-19 patients:

Sponsor
Title
Study type
Primary Outcome Measure
Link
University of Pecs, Hungary
Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure (CYTOAID)
Prospective observational cohort
Change in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy
Brugmann University Hospital Brussels
Determination of the hemoadsorption impact as adjunctive treatment upon the support therapy of COVID-19
Pilot randomized control trial
Change in pro and anti-inflammatory cytokine clearances
University of Zurich, Switzerland
The Risk Stratification in COVID-19 Patients in the ICU Registry (RISC-19-ICU)
Prospective observational international registry
ICU mortality
Jena University Hospital, Germany
International Registry on the Use of the CytoSorb Adsorber (CytoSorb)
Prospective observational international registry
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
Charité – Universitätsmedizin Berlin, Germany
CytoResc – Usage of CytoSorb in COVID-19 associated cytokine storm
Prospective, randomized, controlled, multi-center pilot study
Time to overcome vasoplegic shock
German Clinical Trials Register
University Hospital Freiburg, Germany
Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation (CYCOV-II)
Prospective randomized controlled multi-center study
Interleukin-6 (IL-6) level after 72 hours
ClinicalTrials.gov
University Hospital Freiburg, Germany
Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation (CYCOV)
Prospective randomized controlled single center study
Interleukin-6 (IL-6) level after 72 hours
ClinicalTrials.gov
University Medical Center Hamburg, Germany
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19 (CYTOCOV-19)
Prospective randomized controlled single center study
Percentage of patients with a significant stabilization of hemodynamics (“shock reversal”) for at least 24 hours
ClinicalTrials.gov
Hospital Clinic of Barcelona, Spain
Pilot Study on Cytokine Filtration in COVID-19 ARDS (CytokCOVID19)
Prospective randomized controlled single center study
Mechanical ventilation-free days
ClinicalTrials.gov

Literature

  • RCT – Research Letter including preliminary analysis
    Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation
    Reider M, Wengenmayer T, Staudacher D, Duerschmied D, Supady A.
    Crit Care 2020; 24(1): 435
    CytoSorb Literature Database

     

  • Case Report
    Cytosorb filter: An adjunct for survival in the COVID-19 patient in cytokine storm? a case report.
    Rizvi S, Danic M, Silver M, LaBond V
    Heart & Lung 2020; epub
    CytoSorb Literature Database

  • Case Report
    Cytokine Hemoadsorption in the Management of a Pregnant Woman with COVID-19 Pneumonia: Case Report.
    Karabulut Keklik ES, Dal H, Bozok Ş
    SN Comprehensive Clinical Medicine 2020; epub
    CytoSorb Literature Database

     

  • Case Report
    SARS-CoV-2 infection in kidney transplant recipients: experience of the Italian Marche region
    Maritati F, Cerutti E., Zuccatosta L, Fiorentini A, Finale C, Ficosecco M, Cristiano F, Capestro A, Balestra E, Taruscia D, Vivarelli M, Donati A, Perna GP, Giacometti A, Tavio M, Onesta M, Di Sante L, Ranghino A.
    Transpl Infect Dis 2020: e13377

    CytoSorb Literature Database

     

  • Case Report
    The Combined Use of Tocilizumab and Hemoadsorption in a Patient with SARS-COV-2-19-Associated Pneumonia: A Case Report
    Berlot G, Tomasini A, Roman Pognuz E, Randino A, Chiella F, La Fata C, Piva M,  Amato P, di Maso V, Bianco F, Gerini U, Tomietto P, Trenti T.
    Nephron 2020; 114(9): 459 – 62
    CytoSorb Literature Database

     

  • Letter to the Editor
    Extracorporeal Hemoadsorption: An option for COVID-19 associated Cytokine Storm syndrome
    Napp C, Bauersachs J.
    Shock 2020; 54(5): 700 – 1
    CytoSorb Literature Database

     

  • Review
    Cytokine Storm in COVID-19: The Current Evidence and Treatment Strategies
    Tang Y, Liu J, Zhang D, Xu Z, Ji J, Wen C.
    Frontiers in Immunology 2020; 11: 1708
    CytoSorb Literature Database

  • Review
    Weathering the Cytokine Storm in COVID-19: Therapeutic Implications
    Iannaccone G, Scacciavillani R, Del Buono MG, Camilli M, Ronco C, Lavie CJ,  Abbate A, Crea F, Massetti M, Aspromonte N.
    Cardiorenal Med 2020: 10(5); 277 – 87
    CytoSorb Literature Database

     

  • Review
    The trinity of COVID-19: immunity, inflammation and intervention
    Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP.
    Nat Rev Immunol 2020; 20(6): 363-374
    CytoSorb Literature Database

     

  • Case of the week 44/2020
    Cytokine adsorption in a patient with severe coronavirus disease 2019 related acute respiratory distress syndrome requiring extracorporeal membrane oxygenation therapy: A case report

    Marina Rieder, Timm Zahn, Christoph Benk, Achim Lother, Christoph Bode, Dawid Staudacher, Daniel Duerschmied, Alexander Supady
    University of Freiburg, Freiburg, Germany, University of Heidelberg, Heidelberg, Germany
    Artif Organs 2020; epub
    CytoSorb Literature Database

  • Case of the week 43/2020

    CytoSorb in a critically ill SARS-CoV-2 positive patient with multiple organ failure
    Dr. Grzegorz Kieroński and Dr. Wojciech Serednicki | Department of Anesthesiology and Intensive Care, Jagiellonian University Collegium Medicum, Krakow, Poland
    CytoSorb Literature Database

  • Case of the week 42/2020

    Use of CytoSorb in a patient with severe COVID-19
    Cesar Mercado1, Emilio Rey2, Jorge Rico3, Rodrigo Daza4, Nehomar Pájaro5, Greisy González1, Jaime Gómez1  
    1Colombian Association of Nephrology, Bucaramanga, Colombia  | 2Hospital Universitario La Samaritana, Bogotá, Colombia  | 3Colombian Association of Nephrology Medellin, Colombia | 4Colombian Association of Nephrology Cartagena, Colombia | 5
    Department of Internal Medicine, University of Sinu, Cartagena, Colombia
    CytoSorb Literature Database

  • Case of the week 39/2020
    Use of CytoSorb in a COVID-19-infected patient with urolithiasis
    Dr. Antoni Okniński | Department for Anesthesiology and Intensive Care Medicine, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

    CytoSorb Literature Database

     

  • Case of the week 38/2020
    Use of CytoSorb in a patient with severe ARDS following COVID-19 pneumonia
    Dirk Buchwald (1), Roland Köditz (2), Justus Strauch (1) | Department of Cardiac Surgery and Thoracic Surgery (1)
    Medical Clinic I, General Internal Medicine (2)
    BG University Hospital Bergmannsheil gGmbH, Germany
    CytoSorb Literature Database

     

  • Case of the week 37/2020
    CytoSorb in a patient with severe respiratory failure caused by SARS-CoV-2 Infection
    Dr. Wojciech Serednicki and Dr. Grzegorz Kieroński
    Department of Anesthesiology and Intensive Care, Jagiellonian University Collegium Medicum, Krakow, Poland
    CytoSorb Literature Database 

     

  • Case of the week: 27 / 2020
    Use of CytoSorb in severe ARDS due to corona virus infection
    PD Dr. med. Stephan Ziegeler, Department for Anesthesiology, Operative Intensive Care Medicine, Pain Therapy, Emergency Medicine, Ibbenbüren Hospital, Germany
    CytoSorb Literature Database

     

  • Case of the Week: 26 / 2020
    Use of CytoSorb in a COVID-19-positive patient with severe ARDS
    Dr. Antoni Okniński Department for Anesthesiology and Intensive Care Medicine, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
    CytoSorb Literature Database

     

  • Case of the Week: 25 / 2020
    Use of CytoSorb in a multi-morbidity patient with ARDS in the context of a COVID-19 infection
    Dr. Holger Fey, Department for Internal Intensive Care Medicine, Fürth Hospital, Germany
    CytoSorb Literature Database

     

  • Case of the Week: 24 / 2020
    Use of CytoSorb in COVID-19 pneumonia with accompanying bacterial superinfection
    Dr. Florian Wunderlich-Sperl, St. Pölten, Austria
    CytoSorb Literature Database

  • Case of the Week: 22 / 2020
    Use of CytoSorb in severe ARDS after COVID-19 infection
    Dr. Alexander Vogt, University Hospital Halle (Saale), Germany
    CytoSorb Literature Database

  • Case of the Week: 21 / 2020
    Use of CytoSorb in a patient with severe ARDS following COVID-19 infection
    Dr. Manuel Garcia Montesinos and Dr. Angel Orera Pérez, Navarra, Spain
    CytoSorb Literature Database

     

  • Case of the Week: 23 / 2020
    Use of CytoSorb in combination with ECMO and CVVHD in a patient with ARDS and SARS-CoV2 infection
    Shekhar Saha, Dietmar Wassilowsky, Sven Peterss, Christian Hagl, Dominik Joskowiak, Munich, Germany
    CytoSorb Literature Database

Coding of COVID-19 patients

WHO has assigned a temporary diagnoses code for COVID-19 patients.

  • U07.1 COVID-19, virus identified by laboratory test and
  • U07.2 COVID-19, virus not identified

For ICD-10-WHO these are primary codes. For the German Modification ICD-10-GM these are secondary codes:

  • U07.1! COVID-19, virus identified by laboratory test and
  • U07.2! COVID-19, virus not identified

These codes shall be used with immediate effect of relevant cases.

Coding of CytoSorb with COVID-19 patients

When CytoSorb is being used in COVID-19 patients it is coded and reimbursed as usual. If you need further information, please have a look here.

Webinars

Webinar recording from October 8: Rationale and Practical use of CytoSorb, an Extracorporeal Cytokine Adsorber, with ECMO to Treat Cytokine Storm in Critically-Ill COVID-19 patients

Webinar recording from 25 June 2020: Rationale for the use of CytoSorb in ECMO patients, cytokine adsorption in severe COVID-19 pneumonia requiring ECMO, first clinical experiences in the USA and reduction of hyperinflammation, septic shock and MOF

Chair: Roberto Lorusso, Maastricht/The Netherlands

Speakers: L. Christian Napp, Hannover/Germany; Alexander Supady, Freiburg/Germany; Nader Moazami, New York/USA; Ali Akil, Ibbenbueren/Germany

Play Video

Webinar recording from 20 May 2020:
Impact of microcirculation, inflammation and cytokine adsorption in COVID-19 patients and possible therapeutic options

Chair: Prof. Mervyn Singer, London, UK

Speakers: Dr. Axel Nierhaus, Hamburg, Germany; Prof. Dr. Can Ince, Rotterdam, The Netherlands; Dr. Ricard Ferrer, Barcelona, Spain; Prof. Dr. Daniel Dürschmied, Freiburg, Germany

Play Video

Webinar recording from 16 April 2020: 
Clinical experiences from treating doctors in COVID-19 epicenters in China and Italy and combination of CytoSorb and ECMO.

Chairs: Prof. John Kellum, Pittsburgh, USA & Prof. Luciano Gattinoni, Göttingen, Germany

Speakers: Prof. Zhiyong Peng, Wuhan, China; Dr. Ivano Riva, Bergamo, Italy; Prof. Giorgio Berlot, Triest, Italy; Dr. Alexander Supady, Freiburg, Germany; Prof. Peter Hegyi, Pecs, Hungary

Play Video

Webinar recording from 26 March 2020:
Background, rationale and criteria for considering CytoSorb therapy in COVID-19 patients

Dr. Volker Humbert
Director Therapy Management, CytoSorbents Europe GmbH

Play Video

Webinar recording from October 8: Rationale and Practical use of CytoSorb, an Extracorporeal Cytokine Adsorber, with ECMO to Treat Cytokine Storm in Critically-Ill COVID-19 patients

Moderators:
Linda Mongero, Vice President, ECLS/ECMO, SpecialtyCare
Luc Puis, Tiny Perfusion Letter

Speakers:
Dr. Phillip Chan, MD, PhD, CEO CytoSorbents Corporation 
Mr. Stefan Sajgo, Ulm University, Ulm Germany

Play Video

Webinar recording from 30 April 2020:Joint Perfusion COVID-19 Task Force: COVID-19 Patient Transport and CytoSorb Use from the "American Society of ExtraCorporeal Technology"

Play Video

Webinar recording from 16 April 2020:
Joint Perfusion COVID-19 Task Force: COVID-19 In Practice Third Webinar from the "American Society of ExtraCorporeal Technology"

Play Video

Statements made during the presentations are non-binding and cannot replace the therapy decisions of the treating physician, who is in all cases responsible for the development and implementation of an adequate diagnostic and therapeutic plan for each individual patient. The clinical and preclinical data and results obtained with the CytoSorb adsorber are not transferable to other products.

CytoSorb should only be administered by personnel who have been properly trained in administration of extracorporeal therapies.

We are here for you

Let us answer any questions related to CytoSorb Therapy use in COVID-19 patients.

  1. CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses.

    On 10 April 2020 CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.
    In the USA:

    • The CytoSorb device has neither been cleared or approved for the indication to treat patients with COVID-19 infection.
    • The CytoSorb device has been authorized by FDA under an Emergency Use Authorization (EUA).
    • The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device undersection 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  1. Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Resp Med 2020;8(3):240-241.
  2. Brescia Renal Covid Task Force : Alberici F et al., GESTIONE DEL PAZIENTE IN DIALISI E CON TRAPIANTO DI RENE IN CORSO DI INFEZIONE DA CORONAVIRUS COVID-19, published March 18th by the Italian Society of Nephrology and by ERA-EDTA
  3. Asociación Panameña de Medicina Critica y Terapia Intensiva, GUÍAS NACIONALES DE ATENCIÓN DE PACIENTES ADULTOS COVID-19 VERSION 2.0, published on March 22nd
  4. Consenso colombiano de expertos sobre recomendaciones informadas en la evidencia para la prevención, diagnóstico y manejo de la lesión renal aguda por SARS- CoV-2/COVID-19, Revista Colombiana de Nefrología Publicación anticipada en línea, Versión en línea 2500-5006
  5. Liang T (editor-in-Chief). Handbook of COVID-19 Prevention and Treatment, The First Affiliated Hospital, Zhejiang University School of Medicine, Compiled According to Clinical Experience. 
  6. China National Health Commission.  Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatment (7th Edition)
  7. Rieder M et al. Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation, Critical Care (2020) 24:435
  8. Berlot G et al. The Combined Use of Tocilizumab and Hemoadsorption in a Patient with SARS-COV-2- 19-Associated Pneumonia: A Case Report, Nephron 2020, epub
  9. Maritati F et al. SARS-CoV-2 INFECTION IN KIDNEY TRANSPLANT RECIPIENTS: EXPERIENCE OF THE ITALIAN MARCHE REGION, TID 2020, epub