Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Direct extracorporeal removal of inflammatory mediators with various adsorbents has been
      suggested as a novel treatment modality for COVID-19 patients. Study determined safety,
      feasibility and effectiveness of clinical use of a hemoperfusion (HP) with a novel styrene-
      divinylbenzene copolymer (SDC) adsorbers to remove pro-inflammatory molecules from the
      bloodstream of COVID-19 patients.
    

Detailed description: 
      When a coronavirus is affected, the inflammatory process develops in a wide variety of organs
      and, in combination with a lack of oxygen, can lead to multiple organ failure. Acute
      respiratory distress syndrome (ARDS), seen in severe COVID-19, is characterized by shortness
      of breath and low blood oxygen levels. As a result, some patients may develop secondary
      bacterial and fungal infections. ARDS can lead to respiratory failure, which is the cause of
      death in 70% of COVID-19 deaths. In addition, the powerful release of cytokines by the immune
      system in response to viral infection and / or secondary infections can lead to symptoms of
      sepsis, which is the cause of death in 28% of COVID-19 cases, due to uncontrolled
      inflammation leading to multiple organ failure.

      Most SARS-CoV patients who develop kidney failure end up dying. There is still no definitive
      answer to the question of why some COVID-19 patients are so severe - this may be partly due
      to concomitant diseases, although according to preliminary data from different countries it
      can be concluded that blocking the hyperactivation of immunity at the levels of IL-1 and IL-
      6 may be effective in treating patients with severe coronavirus by suppressing or preventing
      cytokine storms.

      Currently being treated COVID-19 is purely supportive. The main cause of death in seriously
      ill patients is acute respiratory failure. A possible reason for the development of this
      condition may be a cytokine storm, leading to acute decompensation of patients, which may be
      a possible direction of therapeutic intervention.

      One of the main reasons for the high mortality rate of patients with the new coronavirus
      infection COVID-19 is the lack of etiotropic therapy. In this regard, pathogenetic therapy,
      aimed at key factors in the pathogenesis of emerging critical conditions, acquires great
      importance for saving the lives of patients.

      Various pathogenetic treatment options are currently being discussed for the treatment of
      COVID-19, including selective inhibitors of various interleukins and extracorporeal cytokine
      elimination. So far, there is no convincing evidence of the effectiveness of the use of
      COVID-19 for any of them.

      Nevertheless, according to many researchers, taking into account the peculiarities of
      pathogenesis, an important place in the pathogenetic treatment of patients with severe course
      of coronavirus infection should be occupied by methods of extracorporeal hemocorrection. They
      have complex multiple effects and can quickly normalize the level of cytokines and other
      factors of pathogenesis and thereby prevent or reduce the severity of organ disorders.

      When planning this clinical trial, it was suggested that hemosorption of cytokines could
      improve outcome in critically ill COVID-19 patients with suspected cytokine storms.

      Hemosorption device Efferon CT provides a decrease in high concentrations of endogenous
      mediators of the systemic inflammatory response, incl. cytokines leading to the development
      of multiple organ failure and other pathophysiological disorders. The device for hemosorption
      Efferon CT has a high adsorption capacity and biocompatibility.

      Efferon CT (Efferon JSC, Moscow, Russia) - a device for extracorporeal blood purification
      using direct hemoperfusion. Detoxification is carried out by removing excess cytokines,
      myoglobin, endogenous and exogenous toxic substances from the patient's blood.

      Efferon СT is a cylindrical polycarbonate body filled with spherical granules of a polymeric
      cross-linked porous hemosorbent based on a hypercrosslinked styrene-divinylbenzene copolymer
      and isotonic sodium chloride solution.

      The device is manufactured according to TU 32.50.50-001-12264678-2018, passed the necessary
      tests and is registered in Russia as a medical device RZN 2019/8886.
    

Intervention name(s): Efferon CT
Intervention type(s): Device
Intervention description(s): extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        42 COVID-19, PCR+ patients, age <81 years, average 63 (SD range, 54-69) years, 52% men
      
Keywords: COVID-19; mesoporous styrene-divinylbenzene copolymer; cytokines adsorption; hemoperfusion