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 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 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 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 750 critically ill patients with COVID-19 infection have been treated with CytoSorb in various centers in Italy, China and Germany.
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 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 also been investigating the effects of the therapy in investigator-initiated studies. These studies are completely independent from CytoSorbents.
Studies initiated by CytoSorbents Europe:
- Observational multicentric international study on CytoSorb in COVID-19 patients with mirror control registry (more information to follow soon)
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
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Guidelines & Links
Emergency Use Authorization (EUA) issued by the US Food and Drug Administration (FDA)
Links to reliable sources
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 intensive care. Lancet Resp Med 2020;8(3):240-241.
