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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06402279
• Other study ID #: efferon-ct-2020-02
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2024
• Source: Efferon JSC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 1, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Efferon CT
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.

Locations

Country	Name	City	State
Russian Federation	Alexey Yakovlev	Nizhny Novgorod

Sponsors (1)

Lead Sponsor	Collaborator
Efferon JSC

Country where clinical trial is conducted

Russian Federation, 

Outcome

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