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

NCT05104398 | Completed

• 1 other identifier: efferon-ct-2021-02
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; mesoporous styrene-divinylbenzene copolymer; cytokines adsorption; hemoperfusion

Outcome Measures

Primary Outcomes (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

  1-120 hours

Secondary Outcomes (4)

• Effect of Efferon CT hemoperfusion on SOFA scores

  1-120 hours

• Effect of Efferon CT hemoperfusion on IL-6 levels

  1-120 hours

• Effect of Efferon CT hemoperfusion on Ferritin levels

  1-120 hours

• Effect of Efferon CT hemoperfusion on Lactate levels

  1-120 hours

Study Arms (2)

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

Interventions

Efferon CT DEVICE

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

Basic therapy + Efferon CT

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

N.I. Pirogov City Clinical Hospital No. 1

Moscow, 119049, Russia

Location

Related Publications (5)

• 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.

  PMID: 32454500 BACKGROUND

• 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.

  PMID: 32172242 BACKGROUND

• 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.

  PMID: 32087114 BACKGROUND

• 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.

  PMID: 32125452 BACKGROUND

• 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.

  PMID: 32192578 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Timur Kim, MD

  N.I. Pirogov Clinical City Hospital No. 1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 3, 2021
• Study Start: October 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)