Hemoperfusion Efferon СT for the Extremely Severe Form of COVID-19

NCT ID: NCT06402279

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-12-01

Brief 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. 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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Efferon CT therapy

Intervention Type: DEVICE

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.

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.

No interventions assigned to this group

Interventions

Efferon CT therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yakovlev Alexey, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Nizhny Novgorod regional clinical hospital named after N.A.Semashko

Locations

Alexey Yakovlev

Nizhny Novgorod, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 40115785 (View on PubMed)

Other Identifiers

efferon-ct-2020-02

Identifier Type: -

Identifier Source: org_study_id