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

NCT06402279 | Completed

• 1 other identifier: efferon-ct-2020-02
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effect of Efferon CT hemoperfusion on Ventilator-free days (VFDs)

  VFDs is a composite outcome measure that combines survival and duration of ventilation.

  1-60 days

Secondary Outcomes (4)

• Effect of Efferon CT hemoperfusion on SOFA scores

  1-10 days

• Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function

  1-10 days

• Effect of Efferon CT hemoperfusion on KDIGO stage

  1-10 days

• Effect of Efferon CT hemoperfusion on the need for norepinephrine

  1-10 days

Study Arms (2)

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.

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.

Interventions

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.

Basic therapy + Efferon CT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

Alexey Yakovlev

Nizhny Novgorod, Russia

Location

Related Publications (1)

• 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.

  PMID: 40115785 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yakovlev Alexey, PhD,MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 7, 2024
• Study Start: October 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: December 1, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

RU (1)