Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19
NCT ID: NCT05104398
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2020-10-01
2021-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Baseline therapy
Group 1 (n=29) continued to receive standard treatment.
No interventions assigned to this group
Basic therapy + Efferon CT
group 2 (n=13) received HP procedure once, for 3-4 hrs, using Efferon CT adsorbers containing mesoporous SDC beads uptaking 6-60 kD molecules followed by continuous veno-venous hemodiafiltration. Group 2 included more severe patients requiring HP support.
Efferon CT
extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules
Interventions
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Efferon CT
extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules
Eligibility Criteria
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Inclusion Criteria
* Primary ICU patients (admitted to the hospital, transfer from another hospital or department less than 72 hours),
* Positive PCR test for SARS-CoV-2,
* PaO2 / FiO2 \<300,
* SOFA ≥ 4 with clinic of organ dysfunction.
Exclusion Criteria
* The presence of signs of a bacterial infection or the addition of secondary purulent-septic complications,
* Cancer (including blood diseases),
* Chronic diseases in the stage of decompensation,
* Recent or ongoing bleeding,
* Syndrome of disseminated intravascular coagulation,
* Thrombocytopenia,
* Patients in terminal condition or receiving palliative care,
* Patients for whom, for any reason, the use of anticoagulants is not safe.
18 Years
81 Years
ALL
No
Sponsors
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Efferon JSC
INDUSTRY
Responsible Party
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Principal Investigators
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Timur Kim, MD
Role: PRINCIPAL_INVESTIGATOR
N.I. Pirogov Clinical City Hospital No. 1
Locations
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N.I. Pirogov City Clinical Hospital No. 1
Moscow, , Russia
Countries
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References
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Ronco C, Bagshaw SM, Bellomo R, Clark WR, Husain-Syed F, Kellum JA, Ricci Z, Rimmele T, Reis T, Ostermann M. Extracorporeal Blood Purification and Organ Support in the Critically Ill Patient during COVID-19 Pandemic: Expert Review and Recommendation. Blood Purif. 2021;50(1):17-27. doi: 10.1159/000508125. Epub 2020 May 26.
Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.
Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.
Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
Other Identifiers
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efferon-ct-2021-02
Identifier Type: -
Identifier Source: org_study_id