Skip to main content
OpenTrials
Completed

NCT Number: NCT06402279

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexey Yakovlev

Nizhny Novgorod, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efferon CT therapy

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effect of Efferon CT hemoperfusion on SOFA scores

    Time frame: 1-10 days

    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.

  2. Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function

    Time frame: 1-10 days

    Value of oxygenation index (PaO2 / FiO2).

  3. Effect of Efferon CT hemoperfusion on KDIGO stage

    Time frame: 1-10 days

    Degree of acute renal injury.

  4. Effect of Efferon CT hemoperfusion on the need for norepinephrine

    Time frame: 1-10 days

    The number of people who require continuous administration of norepinephrine

Sponsors and collaborators

Lead sponsor

Efferon JSC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 7, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.