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COVID-19NCT05104398

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

An observational study of COVID-19, run by Efferon JSC at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 81 years
Conditions the study is for
COVID-19
What is being tested?
Efferon CT
Type of treatment
Medical device
How many people
42 participants
Where
1 siteRussia
Study dates
1 Oct 2020to 30 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 81 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 42 COVID-19, PCR+ patients, age <81 years, average 63 (SD range, 54-69) years, 52% men

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • Thrombocytopenia,
  • Patients in terminal condition or receiving palliative care,
  • Patients for whom, for any reason, the use of anticoagulants is not safe.

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • N.I. Pirogov City Clinical Hospital No. 1

    Moscow, 119049

Other trials in Russia

About this study

Official title: Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19

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.

Read the detailed description

When a coronavirus is affected, the inflammatory process develops in a wide variety of organs and, in combination with a lack of oxygen, can lead to multiple organ failure. Acute respiratory distress syndrome (ARDS), seen in severe COVID-19, is characterized by shortness of breath and low blood oxygen levels. As a result, some patients may develop secondary bacterial and fungal infections. ARDS can lead to respiratory failure, which is the cause of death in 70% of COVID-19 deaths. In addition, the powerful release of cytokines by the immune system in response to viral infection and / or secondary infections can lead to symptoms of sepsis, which is the cause of death in 28% of COVID-19 cases, due to uncontrolled inflammation leading to multiple organ failure.

Most SARS-CoV patients who develop kidney failure end up dying. There is still no definitive answer to the question of why some COVID-19 patients are so severe - this may be partly due to concomitant diseases, although according to preliminary data from different countries it can be concluded that blocking the hyperactivation of immunity at the levels of IL-1 and IL- 6 may be effective in treating patients with severe coronavirus by suppressing or preventing cytokine storms.

Currently being treated COVID-19 is purely supportive. The main cause of death in seriously ill patients is acute respiratory failure. A possible reason for the development of this condition may be a cytokine storm, leading to acute decompensation of patients, which may be a possible direction of therapeutic intervention.

One of the main reasons for the high mortality rate of patients with the new coronavirus infection COVID-19 is the lack of etiotropic therapy. In this regard, pathogenetic therapy, aimed at key factors in the pathogenesis of emerging critical conditions, acquires great importance for saving the lives of patients.

Various pathogenetic treatment options are currently being discussed for the treatment of COVID-19, including selective inhibitors of various interleukins and extracorporeal cytokine elimination. So far, there is no convincing evidence of the effectiveness of the use of COVID-19 for any of them.

Nevertheless, according to many researchers, taking into account the peculiarities of pathogenesis, an important place in the pathogenetic treatment of patients with severe course of coronavirus infection should be occupied by methods of extracorporeal hemocorrection. They have complex multiple effects and can quickly normalize the level of cytokines and other factors of pathogenesis and thereby prevent or reduce the severity of organ disorders.

When planning this clinical trial, it was suggested that hemosorption of cytokines could improve outcome in critically ill COVID-19 patients with suspected cytokine storms.

Hemosorption device Efferon CT provides a decrease in high concentrations of endogenous mediators of the systemic inflammatory response, incl. cytokines leading to the development of multiple organ failure and other pathophysiological disorders. The device for hemosorption Efferon CT has a high adsorption capacity and biocompatibility.

Efferon CT (Efferon JSC, Moscow, Russia) - 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.

Efferon СT is a cylindrical polycarbonate body filled with spherical granules of a polymeric cross-linked porous hemosorbent based on a hypercrosslinked styrene-divinylbenzene copolymer and isotonic sodium chloride solution.

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.

Conditions
COVID-19
Being tested
Efferon CT
Keywords
COVID-19, mesoporous styrene-divinylbenzene copolymer, cytokines adsorption, hemoperfusion
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efferon CTDevice

    extracorporeal adsorbers containing mesoporous styrene-divinylbenzene copolymer to remove pro-inflammatory 6-60 kD molecules

Study groups in NCT05104398
Study groupRoleWhat they receive
Baseline therapyGroup 1 (n=29) continued to receive standard treatment.
Basic therapy + Efferon CTgroup 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.
Receives: Device: Efferon CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function

    Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours

    Measured: 1-120 hours

Secondary outcomes (4)
  1. Effect of Efferon CT hemoperfusion on SOFA scores

    Value of indicators on the SOFA scale every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours

    Measured: 1-120 hours

  2. Effect of Efferon CT hemoperfusion on IL-6 levels

    Value of IL-6 levels from the start of hemoperfusion (hour 0) to 120 hours

    Measured: 1-120 hours

  3. Effect of Efferon CT hemoperfusion on Ferritin levels

    Value of Ferritin levels from the start of hemoperfusion (hour 0) to 120 hours

    Measured: 1-120 hours

  4. Effect of Efferon CT hemoperfusion on Lactate levels

    Value of Lactate levels from the start of hemoperfusion (hour 0) to 120 hours

    Measured: 1-120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2021
  2. Study start1 Oct 2020
  3. Primary completion30 Jan 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05104398
Sponsor's protocol ID
efferon-ct-2021-02
Status last verified
Oct 2021
First submitted
31 Oct 2021
Last updated
3 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ronco C, Bagshaw SM, Bellomo R, Clark WR, Husain-Syed F, Kellum JA, Ricci Z, Rimmele T, Reis T, Ostermann M. Extracorporeal Blood Purification and Organ Support in the Critically Ill Patient during COVID-19 Pandemic: Expert Review and Recommendation. Blood Purif. 2021;50(1):17-27. doi: 10.1159/000508125. Epub 2020 May 26.

    PubMed 32454500
  • Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.

    PubMed 32172242
  • Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.

    PubMed 32087114
  • Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

    PubMed 32125452
  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PubMed 32192578

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Efferon JSC at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function (time frame: 1-120 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05104398, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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