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

The development of acute respiratory and renal failure of COVID-19 patients is associatedwith an excessive immune response and hyperproduction of anti-inflammatory cytokines,which leads to impaired endothelial function and a dysregulated balance between thecoagulation and fibrinolytic systems in the blood. These factors contribute to thedevelopment of multi-organ failure, sepsis, and high mortality rates.In the absence ofeffective etiotropic therapy for COVID-19, it is necessary to search for alternative,pathogenetically based treatment approaches, including extracorporeal methods ofhomeostasis support. This observational study examines the effect of early hemoperfusionusing the Efferon CT device for the treatment of patients with severe forms of COVID-19after 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.

Completed
COVID-19

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Russia
Locations

Alexey Yakovlev
Nizhny Novgorod 520555, Russia

Yakovlev Alexey, PhD,MD, Principal Investigator
Nizhny Novgorod regional clinical hospital named after N.A.Semashko

NCT Number
Keywords
Covid-19
mesoporous styrene-divinylbenzene copolymer
cytokines adsorption
hemoperfusion
MeSH Terms
COVID-19