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NCT Number: NCT04478539

Extracorporeal Blood Purification as a Treatment Modality for COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Cytokine Release Syndrome Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Shock Systemic Inflammatory Response Syndrome Thrombophilia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zan Mitrev Clinic

Skopje, 1000, North Macedonia

About this study

COVID-19 disease progression is associated with dysregulated immunity, commonly referred to as cytokine storm, in particular, aberrant Interleukin (IL) 6 levels that promote numerous pathological downstream effects. Hyperinflammation is a well-established trigger of multiorgan failure, for example, acute kidney injury. Moreover, recent reports point to a link between hyper inflammation and COVID-19 induced coagulopathy as a result of increased production of clotting factors by the liver.

Despite several lines of evidence pointing to a potential clinical benefit of controlling hyperinflammation triggered by COVID-19, management of COVID-19 remains mostly supportive built around continuous respiratory support.

To this end, considering the underlying immunological character of COVID-19 disease and the high risk of SARS-CoV-2 hyperinflammation to trigger ARDS, hypercoagulability and Acute Kidney Injury (AKI) this study aims to monitor selected biochemical, immunological and coagulation parameters in combination with radiological imaging to guide clinical practice and to tailor therapy consisting of 1) early initiation of blood purification using the oXiris® (AN69ST) filter, 2) systemic heparinisation and 3) respiratory support

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed COVID-19 disease:

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

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

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

    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

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

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

    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.

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

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

    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.

  4. Changes in the coagulation marker Fibrinogen (g/L)

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

    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

  5. ICU length of stay after admission (days)

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

    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.

Secondary outcomes

  1. Changes in Neutrophil-to-Lymphocyte Ratio

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

    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.

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

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

    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

  3. Changes in the Activation Clotting Time (seconds).

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

    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

Sponsors and collaborators

Lead sponsor

Zan Mitrev Clinic

Other

Registry information

Official study title

Clinical Efficacy and Safety of Extracorporeal Blood Purification to Control Hyperinflammation and Hypercoagulability in COVID-19 Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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