Clinical trial NCT06402279: Hemoperfusion Efferon СT for the Extremely Severe Form of COVID-19
Official title: The Effectiveness of Early Hemoperfusion in Patients With Extremely Severe COVID-19 After Intubation on a Ventilator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
mesoporous styrene-divinylbenzene copolymer
cytokines adsorption
hemoperfusion
Lead sponsor: Efferon JSC
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Efferon CT hemoperfusion on Ventilator-free days (VFDs)
timeFrame: 1-60 days
Secondary outcomes:
measure: Effect of Efferon CT hemoperfusion on SOFA scores
timeFrame: 1-10 days
measure: Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
timeFrame: 1-10 days
measure: Effect of Efferon CT hemoperfusion on KDIGO stage
timeFrame: 1-10 days
measure: Effect of Efferon CT hemoperfusion on the need for norepinephrine
timeFrame: 1-10 days
Other outcomes:
Locations:
city: Nizhny Novgorod
country: Russian Federation
facility: Alexey Yakovlev
Study officials:
affiliation: Nizhny Novgorod regional clinical hospital named after N.A.Semashko
name: Yakovlev Alexey, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.