Extracorporeal Blood Purification as a Treatment Modality for COVID-19

NCT04478539 | Completed DMC FDA Device

• 1 other identifier: EBPZ.357
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have suggested a potential clinical benefit of controlling hyper inflammation triggered by SARS-CoV-2/COVID-19. Blood purification, the removal of excessive proinflammatory mediators may control disease progression and support clinical recovery. For this purpose, COVID-19 patients might benefit from treatment with AN69ST hemofilter based extracorporeal blood purification.

Conditions

Covid19

Keywords

SARS-CoV-2; cytokine storm; Interleukin 6; hypercoagulability; Fibrinogen; D-dimer

Outcome Measures

Primary Outcomes (5)

• Changes in cytokine levels of Interleukin (IL) 6, IL-8 and Tumor Necrosis Factor-α (pg/mL)

  Systemic levels of IL-6, IL-8 and TNF-α are evaluated to assess the effect of blood purification. Measurement points: at admission, "before and after a blood purification cycle" and before discharge

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• Changes in inflammatory markers; C-Reactive Protein (CRP) (mg/L)

  Systemic levels of proinflammatory mediators are measured as a marker for disease severity. Measurement points: at admission, "before and after a blood purification cycle" and before discharge.

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• Changes in thrombocyte counts (10^3 counts/microL)

  Systemic levels of thrombocytes are measured as a marker for disease severity. Measurement points: at admission, "before and after a blood purification cycle" and before discharge.

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• Changes in the coagulation marker Fibrinogen (g/L)

  Coagulation markers will be followed to assess the effect of systemic heparinisation, Measurement points, at admission, "before and after a blood purification cycle" and before discharge

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• ICU length of stay after admission (days)

  Duration of intensive care will be determined in relation to the number of blood purification cycles Patients will be followed for the duration of ICU stay.

  An expected average of 4 - 14 hospitalisation days or until hospital discharge (whichever comes first)

Secondary Outcomes (3)

• Changes in Neutrophil-to-Lymphocyte Ratio

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• Changes in the coagulation marker D-Dimers (ng/mL)

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

• Changes in the Activation Clotting Time (seconds).

  Hospitalisation window, day 0 until day 14 or until hospital discharge (whichever comes first)

Study Arms (1)

COVID-19 patients admitted to the ICU

COVID-19 patients will be treated with the Prismaflex® oXiris® system in the ICU. Treatment will be initiated within 4 - 12 hours after admission upon establishing control of the haemostasis, ACT = Activated Coagulation Time of 180 seconds

Device: Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter

Interventions

Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter DEVICE

Admitted patients will receive at least 1 cycle of extracorporeal blood purification using the oXiris® (AN69ST) hemofilter (Baxter, IL, USA). The number of cycles of blood purification is determined based on multiple biochemical, immunological, coagulation parameters, radiological imaging and overall clinical condition. The patient is connected to the Prismaflex® oXiris® system via a double lumen catheter placed in the femoral vein or vena subclavia. Flow rates will be maintained as follow; effluent dose 35 mL/Kg/h, dialysate 14 - 16 mL/Kg/h, blood 150 mL/min, replacement 16 -18 mL/Kg/h; patient fluid removal is tailored to the individual's volume status, ≈ 100 - 250 mL/h. The oXiris® extracorporeal and organ support modality will be chosen according to the patient's kidney function; continuous venovenous hemofiltration (CVVH), continuous venovenous hemodiafiltration (CVVHDF) or slow continuous ultrafiltration (SCUF).

COVID-19 patients admitted to the ICU

Eligibility Criteria

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

Study Population

COVID positive patients admitted to ICU

You may qualify if:

• Confirmed COVID-19 disease:
• RT-PCR
• Atypical Pneumonia; X-Ray and/or Computed Tomography
• ≥ 1 oXiris® blood purification cycle

You may not qualify if:

• Pregnancy
• Heart failure; severe systolic dysfunction, left ventricular ejection fraction \< 25% requiring urgent surgery
• Aortic Aneurysms, dissection or rupture requiring urgent surgery
• Recent Myocardial Infarction; cardiovascular disease patients requiring urgent surgery

Sponsors & Collaborators

• Zan Mitrev Clinic: lead

Study Sites (1)

Zan Mitrev Clinic

Skopje, 1000, North Macedonia

Location

Related Publications (5)

• Malard B, Lambert C, Kellum JA. In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp. 2018 May 4;6(1):12. doi: 10.1186/s40635-018-0177-2.

  PMID: 29728790 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

• The Lancet Haematology. COVID-19 coagulopathy: an evolving story. Lancet Haematol. 2020 Jun;7(6):e425. doi: 10.1016/S2352-3026(20)30151-4. No abstract available.

  PMID: 32470428 BACKGROUND

• Herold T, Jurinovic V, Arnreich C, Lipworth BJ, Hellmuth JC, von Bergwelt-Baildon M, Klein M, Weinberger T. Elevated levels of IL-6 and CRP predict the need for mechanical ventilation in COVID-19. J Allergy Clin Immunol. 2020 Jul;146(1):128-136.e4. doi: 10.1016/j.jaci.2020.05.008. Epub 2020 May 18.

  PMID: 32425269 BACKGROUND

• Zhang Y, Yu L, Tang L, Zhu M, Jin Y, Wang Z, Li L. A Promising Anti-Cytokine-Storm Targeted Therapy for COVID-19: The Artificial-Liver Blood-Purification System. Engineering (Beijing). 2021 Jan;7(1):11-13. doi: 10.1016/j.eng.2020.03.006. Epub 2020 Mar 20. No abstract available.

  PMID: 32292628 BACKGROUND

Related Links

• FDA Emergency Use Authorization for Oxiris Blood Purification Filter for COVID-19 Treatment

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome; Thrombophilia

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; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zan K Mitrev, MD

  Zan Mitrev Clinic

  STUDY DIRECTOR

• Rodney A Rosalia, PhD

  Zan Mitrev Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: June 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)