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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 88,000 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 750 critically ill patients with COVID-19 infection have been treated with CytoSorb in various centers in Italy, China and Germany. 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. (3) 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. (4) 

Options for actions &
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...

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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We are here for you

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Options for actions &
Rationale of use

Download updates about COVID-19 & CytoSorb Therapy

You will need Adobe Acrobat Reader (PDF) or a book reader (epub) for best view options, and you can download this program free of charge from the Internet.

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
CytoSorb in COVID-19 patients with mirror control registry
Observational multicentric international study
improvement in paO2/FiO2
more information to follow soon
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 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)
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

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 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

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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

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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

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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. 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.