COVID-19NCT05104398
Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19
An observational study of COVID-19, run by Efferon JSC at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Efferon CT
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 42 COVID-19, PCR+ patients, age <81 years, average 63 (SD range, 54-69) years, 52% men
Who may be able to join
- Men and women aged 21-80,
- 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.
Who cannot join
- Pregnancy,
- 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,
Show all 9Show fewer
- Thrombocytopenia,
- Patients in terminal condition or receiving palliative care,
- Patients for whom, for any reason, the use of anticoagulants is not safe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Efferon CT
- Keywords
- COVID-19, mesoporous styrene-divinylbenzene copolymer, cytokines adsorption, hemoperfusion
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon CTDevice
extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules
| Study group | Role | What they receive |
|---|---|---|
| Baseline therapy | Group 1 (n=29) continued to receive standard treatment. | |
| 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. Receives: Device: Efferon CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours
Measured: 1-120 hours
Secondary outcomes (4)
Effect of Efferon CT hemoperfusion on SOFA scores
Value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours
Measured: 1-120 hours
Effect of Efferon CT hemoperfusion on IL-6 levels
Value of IL-6 levels from the start of hemoperfusion (hour 0) to 120 hours
Measured: 1-120 hours
Effect of Efferon CT hemoperfusion on Ferritin levels
Value of Ferritin levels from the start of hemoperfusion (hour 0) to 120 hours
Measured: 1-120 hours
Effect of Efferon CT hemoperfusion on Lactate levels
Value of Lactate levels from the start of hemoperfusion (hour 0) to 120 hours
Measured: 1-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Oct 2020
- Primary completion30 Jan 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timur Kim, MD, Principal investigator, N.I. Pirogov Clinical City Hospital No. 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104398
- Sponsor's protocol ID
- efferon-ct-2021-02
- Status last verified
- Oct 2021
- First submitted
- 31 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32454500Ronco 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.
PubMed 32172242Dong 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.
PubMed 32087114Ruan 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.
PubMed 32125452Mehta 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.
PubMed 32192578
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19
- ClinicalTrials.gov ID
- NCT05104398
- Acronym / sponsor ID
- efferon-ct-2021-02
- Conditions
- COVID-19
- Keywords
- COVID-19, mesoporous styrene-divinylbenzene copolymer, cytokines adsorption, hemoperfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy | – | –Group 1 (n=29) continued to receive standard treatment. |
| Basic therapy + Efferon CT | – | Device: Efferon CTgroup 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. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 42 COVID-19, PCR+ patients, age <81 years, average 63 (SD range, 54-69) years, 52% men
Key inclusion criteria (5 listed)
- Men and women aged 21-80,
- 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.
Key exclusion criteria (9 listed)
- Pregnancy,
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon CTextracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules | Device | Basic therapy + Efferon CT |
Primary outcome
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Time frame: 1-120 hours
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours
4 secondary outcomes
Effect of Efferon CT hemoperfusion on SOFA scores
Time frame: 1-120 hours
Effect of Efferon CT hemoperfusion on IL-6 levels
Time frame: 1-120 hours
Effect of Efferon CT hemoperfusion on Ferritin levels
Time frame: 1-120 hours
Effect of Efferon CT hemoperfusion on Lactate levels
Time frame: 1-120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 32454500Ronco 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.
- Background: PubMed 32172242Ronco 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.
- Background: PubMed 32087114Dong 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.
- Background: PubMed 32125452Ruan 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.
- Background: PubMed 32192578Mehta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timur Kim, MD principal investigator
N.I. Pirogov Clinical City Hospital No. 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Efferon JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function (time frame: 1-120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104398, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.