Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05104398
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2021-10-31
Brief Title:
Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19
Sponsor:
Efferon JSC
Organization:
Efferon JSC
Study Overview
Official Title:
Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 325050-001-12264678-2018 passed the necessary tests and is registered in Russia as a medical device RZN 20198886
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 patients 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 325050-001-12264678-2018 passed the necessary tests and is registered in Russia as a medical device RZN 20198886
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None