Skip to content

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

The Effectiveness of Early Hemoperfusion in Patients With Extremely Severe COVID-19 After Intubation on a Ventilator

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06402279
Enrollment
130
Registered
2024-05-07
Start date
2020-10-01
Completion date
2023-12-01
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, mesoporous styrene-divinylbenzene copolymer, cytokines adsorption, hemoperfusion

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.

Interventions

DEVICEEfferon 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.

Sponsors

Efferon JSC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of Efferon CT hemoperfusion on Ventilator-free days (VFDs)1-60 daysVFDs is a composite outcome measure that combines survival and duration of ventilation.

Secondary

MeasureTime frameDescription
Effect of Efferon CT hemoperfusion on SOFA scores1-10 daysValue 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.
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function1-10 daysValue of oxygenation index (PaO2 / FiO2).
Effect of Efferon CT hemoperfusion on KDIGO stage1-10 daysDegree of acute renal injury.
Effect of Efferon CT hemoperfusion on the need for norepinephrine1-10 daysThe number of people who require continuous administration of norepinephrine

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026