Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402279
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-05
Brief Title:
Hemoperfusion Efferon СT for the Extremely Severe Form of COVID-19
Sponsor:
Efferon JSC
Organization:
Efferon JSC
Study Overview
Official Title:
The Effectiveness of Early Hemoperfusion in Patients With Extremely Severe COVID-19 After Intubation on a Ventilator
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ratesIn 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 conditionsTimely 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 dysfunctionThe 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 patients blood The device is manufactured according to TU 325050-001-12264678-2018 passed the necessary tests and is registered in Russia as a medical device RZN 20198886
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 patients blood The device is manufactured according to TU 325050-001-12264678-2018 passed the necessary tests and is registered in Russia as a medical device RZN 20198886
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None