COVID-19NCT06402279
Hemoperfusion Efferon СT for the Extremely Severe Form of COVID-19
An observational study of COVID-19, run by Efferon JSC at 1 site in Russia.
Trial summary
The development of acute respiratory and renal failure of COVID-19 patients is associated with an excessive immune response and hyperproduction of anti-inflammatory cytokines, which leads to impaired endothelial function and a dysregulated balance between the coagulation and fibrinolytic systems in the blood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Efferon CT therapy
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2020to 1 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sexes, over 18 years and under 72 years old with extremely severe COVID-19 after the start of mechanical ventilation
Who may be able to join
- Patients with extremely severe COVID-19 no later than 6 hours after the start of intubation on a ventilator
- Patients over 18 years and under 72 years old
Who cannot join
- Pregnancy or the first 3 months after childbirth
- Clinical or laboratory findings of sepsis
- Acute bleeding
- Presense of cancer in anamnesis
- Surgical interventions
- Acute kidney injury (KDIGO > I)
Show all 10Show fewer
- Charlson comorbidity index > 5
- Thrombocytopenia with a platelet count less than 100x109/L
- Patients in the first 6 months after acute cerebrovascular accident or acute myocardial infarction
- Patients who have previously undergone extracorporeal detoxication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Early Hemoperfusion in Patients With Extremely Severe COVID-19 After Intubation on a Ventilator
The development of acute respiratory and renal failure of COVID-19 patients is associated with an excessive immune response and hyperproduction of anti-inflammatory cytokines, which leads to impaired endothelial function and a dysregulated balance between the coagulation and fibrinolytic systems in the blood. These factors contribute to the development of multi-organ failure, sepsis, and high mortality rates.In the absence of effective etiotropic therapy for COVID-19, it is necessary to search for alternative, pathogenetically based treatment approaches, including extracorporeal methods of homeostasis support. This observational study examines the effect of early hemoperfusion using the Efferon CT device for the treatment of patients with severe forms of COVID-19 after their intubation on a ventilator.
Read the detailed description
On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. This disease is characterized by a variety of symptoms, many of which can lead to multiple organ failures and critical conditions.Timely removal of cytokines and other medium-molecular substances from the body using sorption techniques can not only help restore the balance between pro-inflammatory and anti-inflammatory mediators, but also in some clinical situations, prevent the deterioration of vital organ function or create conditions that allow for the reversal of multiple organ dysfunction.The accumulated experience of using various devices for sorption of low- and medium-molecular toxins creates a pathophysiological basis for the development of effective methods for the use of extracorporeal hemoperfusion in the treatment of the most severe forms of COVID-19.
This study examines the effects of early hemoperfusion, using the Efferon CT device, for the treatment of severe cases of COVID-19 in patients after intubation on a ventilator.
Efferon CT (Efferon JSC, Moscow, Russia) is 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. 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 therapy
- 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 CT therapyDevice
Efferon CT is a cylindrical body made of polycarbonate, filled with spherical granules of polymer hemocompatible macroporous styrene-divinylbenzene copolymer of super cross- linked type and isotonic sodium chloride solution. The device is manufactured according to TU 32.50.50-001-12264678-2018, has passed the necessary tests and is registered in Russia as a medical product RZN 2019/8886. Hemoperfusion procedures were performed using the Efferon CT device no later than 6 hours after the start of invasive ventilation. Hemosorption was performed twice within 12 hours, with an interval of 24 hours between hemoperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Basic therapy + Efferon CT | Patients in group 1 (n = 65) received basic COVID-19 medication: 2 to 5 days before hemosorption, they all received anti-inflammatory drugs, glucocorticoid therapy (16 to 24 mg/day of dexamethasone), oxygen therapy, and heparin. The transfer to an intensive care unit (ICU) was accompanied by transfer to a non-invasive ventilator. Receives: Device: Efferon CT therapy | |
| Baseline therapy | Group 2 patients (n=65) were matched to patients of group 1 and received basic COVID-19 drug therapy and no hemoperfusion procedure using Efferon CT device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Efferon CT hemoperfusion on Ventilator-free days (VFDs)
VFDs is a composite outcome measure that combines survival and duration of ventilation.
Measured: 1-60 days
Secondary outcomes (4)
Effect of Efferon CT hemoperfusion on SOFA scores
Value of indicators on the Sequential Organ Failure Assessment (SOFA) Score. Each organ system received a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24.
Measured: 1-10 days
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Value of oxygenation index (PaO2 / FiO2).
Measured: 1-10 days
Effect of Efferon CT hemoperfusion on KDIGO stage
Degree of acute renal injury.
Measured: 1-10 days
Effect of Efferon CT hemoperfusion on the need for norepinephrine
The number of people who require continuous administration of norepinephrine
Measured: 1-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Oct 2020
- Primary completion28 Feb 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yakovlev Alexey, PhD,MD, Principal investigator, Nizhny Novgorod regional clinical hospital named after N.A.Semashko
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402279
- Sponsor's protocol ID
- efferon-ct-2020-02
- Status last verified
- Mar 2025
- First submitted
- 5 May 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yakovlev AY, Ilyin YV, Bershadsky FF, Selivanov DD, Pevnev AA, Trikole AI, Popov AY, Pisarev VM. Efficacy of hemoadsorption in the severe course of COVID-19. Front Med (Lausanne). 2025 Mar 6;12:1491137. doi: 10.3389/fmed.2025.1491137. eCollection 2025.
PubMed 40115785
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Early Hemoperfusion in Patients With Extremely Severe COVID-19 After Intubation on a Ventilator
- ClinicalTrials.gov ID
- NCT06402279
- Acronym / sponsor ID
- efferon-ct-2020-02
- Conditions
- COVID-19
- Keywords
- COVID-19, mesoporous styrene-divinylbenzene copolymer, cytokines adsorption, hemoperfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 May 2024 (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.
The development of acute respiratory and renal failure of COVID-19 patients is associated with an excessive immune response and hyperproduction of anti-inflammatory cytokines, which leads to impaired endothelial function and a dysregulated balance between the coagulation and fibrinolytic systems in the blood. These factors contribute to the development of multi-organ failure, sepsis, and high mortality rates.In the absence of effective etiotropic therapy for COVID-19, it is necessary to search for alternative, pathogenetically based treatment approaches, including extracorporeal methods of homeostasis support. This observational study examines the effect of early hemoperfusion using the Efferon CT device for the treatment of patients with severe forms of COVID-19 after their intubation on a ventilator.
Detailed description
On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. This disease is characterized by a variety of symptoms, many of which can lead to multiple organ failures and critical conditions.Timely removal of cytokines and other medium-molecular substances from the body using sorption techniques can not only help restore the balance between pro-inflammatory and anti-inflammatory mediators, but also in some clinical situations, prevent the deterioration of vital organ function or create conditions that allow for the reversal of multiple organ dysfunction.The accumulated experience of using various devices for sorption of low- and medium-molecular toxins creates a pathophysiological basis for the development of effective methods for the use of extracorporeal hemoperfusion in the treatment of the most severe forms of COVID-19.
This study examines the effects of early hemoperfusion, using the Efferon CT device, for the treatment of severe cases of COVID-19 in patients after intubation on a ventilator.
Efferon CT (Efferon JSC, Moscow, Russia) is 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. 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic therapy + Efferon CT | – | Device: Efferon CT therapyPatients in group 1 (n = 65) received basic COVID-19 medication: 2 to 5 days before hemosorption, they all received anti-inflammatory drugs, glucocorticoid therapy (16 to 24 mg/day of dexamethasone), oxygen therapy, and heparin. The transfer to an intensive care unit (ICU) was accompanied by transfer to a non-invasive ventilator. |
| Baseline therapy | – | –Group 2 patients (n=65) were matched to patients of group 1 and received basic COVID-19 drug therapy and no hemoperfusion procedure using Efferon CT device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes, over 18 years and under 72 years old with extremely severe COVID-19 after the start of mechanical ventilation
Key inclusion criteria (2 listed)
- Patients with extremely severe COVID-19 no later than 6 hours after the start of intubation on a ventilator
- Patients over 18 years and under 72 years old
Key exclusion criteria (10 listed)
- Pregnancy or the first 3 months after childbirth
- Clinical or laboratory findings of sepsis
- Acute bleeding
- Presense of cancer in anamnesis
- Surgical interventions
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 CT therapyEfferon CT is a cylindrical body made of polycarbonate, filled with spherical granules of polymer hemocompatible macroporous styrene-divinylbenzene copolymer of super cross- linked type and isotonic sodium chloride solution. The device is manufactured according to TU 32.50.50-001-12264678-2018, has passed the necessary tests and is registered in Russia as a medical product RZN 2019/8886. Hemoperfusion procedures were performed using the Efferon CT device no later than 6 hours after the start of invasive ventilation. Hemosorption was performed twice within 12 hours, with an interval of 24 hours between hemoperfusion. | Device | Basic therapy + Efferon CT |
Primary outcome
Effect of Efferon CT hemoperfusion on Ventilator-free days (VFDs)
Time frame: 1-60 days
VFDs is a composite outcome measure that combines survival and duration of ventilation.
4 secondary outcomes
Effect of Efferon CT hemoperfusion on SOFA scores
Time frame: 1-10 days
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Time frame: 1-10 days
Effect of Efferon CT hemoperfusion on KDIGO stage
Time frame: 1-10 days
Effect of Efferon CT hemoperfusion on the need for norepinephrine
Time frame: 1-10 days
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 26 Mar 2025.
- Background: PubMed 40115785Yakovlev AY, Ilyin YV, Bershadsky FF, Selivanov DD, Pevnev AA, Trikole AI, Popov AY, Pisarev VM. Efficacy of hemoadsorption in the severe course of COVID-19. Front Med (Lausanne). 2025 Mar 6;12:1491137. doi: 10.3389/fmed.2025.1491137. eCollection 2025.
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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.
Yakovlev Alexey, PhD,MD principal investigator
Nizhny Novgorod regional clinical hospital named after N.A.Semashko
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 2 inclusion and 10 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 26 Mar 2025. 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 Ventilator-free days (VFDs) (time frame: 1-60 days). 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 NCT06402279, which also lists 1 linked publication.
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 26 Mar 2025.