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Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05104398
Recruitment Status : Completed
First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Efferon JSC

Brief Summary:
Direct extracorporeal removal of inflammatory mediators with various adsorbents has been suggested as a novel treatment modality for COVID-19 patients. Study determined safety, feasibility and effectiveness of clinical use of a hemoperfusion (HP) with a novel styrene- divinylbenzene copolymer (SDC) adsorbers to remove pro-inflammatory molecules from the bloodstream of COVID-19 patients.

Condition or disease Intervention/treatment
COVID-19 Device: Efferon CT

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Baseline therapy
Group 1 (n=29) continued to receive standard treatment.
Basic therapy + Efferon CT
group 2 (n=13) received HP procedure once, for 3-4 hrs, using Efferon CT adsorbers containing mesoporous SDC beads uptaking 6-60 kD molecules followed by continuous veno-venous hemodiafiltration. Group 2 included more severe patients requiring HP support.
Device: Efferon CT
extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules




Primary Outcome Measures :
  1. Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function [ Time Frame: 1-120 hours ]
    Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours


Secondary Outcome Measures :
  1. Effect of Efferon CT hemoperfusion on SOFA scores [ Time Frame: 1-120 hours ]
    Value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours

  2. Effect of Efferon CT hemoperfusion on IL-6 levels [ Time Frame: 1-120 hours ]
    Value of IL-6 levels from the start of hemoperfusion (hour 0) to 120 hours

  3. Effect of Efferon CT hemoperfusion on Ferritin levels [ Time Frame: 1-120 hours ]
    Value of Ferritin levels from the start of hemoperfusion (hour 0) to 120 hours

  4. Effect of Efferon CT hemoperfusion on Lactate levels [ Time Frame: 1-120 hours ]
    Value of Lactate levels from the start of hemoperfusion (hour 0) to 120 hours



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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
42 COVID-19, PCR+ patients, age <81 years, average 63 (SD range, 54-69) years, 52% men
Criteria

Inclusion Criteria:

  • Men and women aged 21-80,
  • Primary ICU patients (admitted to the hospital, transfer from another hospital or department less than 72 hours),
  • Positive PCR test for SARS-CoV-2,
  • PaO2 / FiO2 <300,
  • SOFA ≥ 4 with clinic of organ dysfunction.

Exclusion Criteria:

  • Pregnancy,
  • The presence of signs of a bacterial infection or the addition of secondary purulent-septic complications,
  • Cancer (including blood diseases),
  • Chronic diseases in the stage of decompensation,
  • Recent or ongoing bleeding,
  • Syndrome of disseminated intravascular coagulation,
  • Thrombocytopenia,
  • Patients in terminal condition or receiving palliative care,
  • Patients for whom, for any reason, the use of anticoagulants is not safe.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05104398


Locations
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Russian Federation
N.I. Pirogov City Clinical Hospital No. 1
Moscow, Russian Federation, 119049
Sponsors and Collaborators
Efferon JSC
Investigators
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Principal Investigator: Timur Kim, MD N.I. Pirogov Clinical City Hospital No. 1
Publications:
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Responsible Party: Efferon JSC
ClinicalTrials.gov Identifier: NCT05104398    
Other Study ID Numbers: efferon-ct-2021-02
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Efferon JSC:
COVID-19
mesoporous styrene-divinylbenzene copolymer
cytokines adsorption
hemoperfusion
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases