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

Completed

• Conditions: COVID-19
• Interventions: Device: Efferon CT

• Registration Number: NCT06402279
• Lead Sponsor: Efferon JSC

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-02-28
• Study Completion: 2023-12-01
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-22
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Basic therapy + Efferon CT	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of Efferon CT hemoperfusion on KDIGO stage	1-10 days	Degree of acute renal injury.
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function	1-10 days	Value of oxygenation index (PaO2 / FiO2).
Effect of Efferon CT hemoperfusion on SOFA scores	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.
Effect of Efferon CT hemoperfusion on the need for norepinephrine	1-10 days	The number of people who require continuous administration of norepinephrine

Trial Locations

Locations (1)

Alexey Yakovlev; 🇷🇺 Nizhny Novgorod, Russian Federation