COVID-19 & CytoSorb Therapy*
Initial reports suggest that COVID-19 is associated with severe disease that requires critical 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 such as 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 CE marked extracorporeal cytokine adsorber, designed to broadly reduce 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 152,000 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 the cytokine storm in critically-ill COVID-19 patients was recently detailed in 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 7,000 critically ill patients with COVID-19 infection have been treated with CytoSorb in more than 70 countries.
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
CLINICAL ACTIVITIES in COVID-19 patients
At CytoSorbents, we are continuously working to build and further expand the already existing 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-marked, clinicians have also been investigating the effects of the therapy in investigator-initiated studies.
Studies initiated by CytoSorbents:
- Registry of CytoSorb Therapy in COVID-19 ICU Patients
Prospective observational study (patient registry)
Primary Outcome Measure: 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:
- 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
Primary Outcome Measure: Change in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy
ClinicalTrials.gov - Brugmann University Hospital Brussels
Determination of the hemoadsorption impact as adjunctive treatment upon the support therapy of COVID-19
Pilot randomized control trial
Primary Outcome Measure: Change in pro and anti-inflammatory cytokine clearances
ClinicalTrials.gov - University of Zurich, Switzerland
The Risk Stratification in COVID-19 Patients in the ICU Registry (RISC-19-ICU)
Prospective observational international registry
Primary Outcome Measure: ICU mortality
RISC-19-ICU
ClinicalTrials.gov - Jena University Hospital, Germany
International Registry on the Use of the CytoSorb Adsorber (CytoSorb)
Prospective observational international registry
Primary Outcome Measure: Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
CytoSorb Registry
ClinicalTrials.gov - Charité – Universitätsmedizin Berlin, Germany
CytoResc – Usage of CytoSorb in COVID-19 associated cytokine storm
Prospective, randomized, controlled, multi-center pilot study
Primary Outcome Measure: 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
Primary Outcome Measure: 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
Primary Outcome Measure: 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
Primary Outcome Measure: Mechanical ventilation-free days
ClinicalTrials.gov
Guidelines & Links
Emergency Use Authorization (EUA) issued by the US Food and Drug Administration (FDA)
Links to reliable sources
Webinars
Webinar Recording from September 13, 2021:
CytoSorbents Webinar: CTC Multicenter Registry | CytoSorb Therapy with ECMO in COVID-19
J.W. Awori Hayanga, MD, MPH, FACS
West Virginia University and WVU Heart and Vascular Institute
Phillip Chan, MD, PhD
Chief Executive Officer – CytoSorbents Corporation
Webinar Recording from March 4, 2021:
CytoSorb Therapy in critically ill COVID-19 patients – actual results and best practice
International Expert Meeting, Intensive Care
Chair:
Prof. Didier Payen, Nice/France
Speakers:
Prof. Didier Payen, Nice/France | Dr. Axel Nierhaus, Hamburg/Germany | Prof. Manu Malbrain, Brussels/Belgium
Webinar Recording from October 29, 2020:
7th International CytoSorb Users’ Meeting
Moderators:
Axel Nierhaus, Germany | Giorgio Berlot, Italy | Ahmad Assiri, Iran | Michael Firstenberg, USA | José Ernesto López Almaraz, Mexico
Webinar Recording from October 8, 2020:
Rationale and Practical use of CytoSorb, an Extracorporeal Cytokine Adsorber, with ECMO to Treat Cytokine Storm in Critically-Ill COVID-19 patient
Chair:
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
Webinar Recording from March 26, 2020:
CytoSorb therapy in COVID-19 patients
Dr. Volker Humbert, Director Therapy Management
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.
Press Releases
We are here for you
Let us answer any questions related to CytoSorb Therapy use in COVID-19 patients.
- 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.
- Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in critical care. Lancet Resp Med 2020;8(3):240-241.