NCT06402279

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
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Efferon JSC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-02-28
• Completion: 2023-12-01
• First posted: 2024-05-07
• Last updated: 2025-03-26

Locations

1 site across 1 country: Russia