Extracorporeal Blood Purification as a Treatment Modality for COVID-19
- Conditions
- Covid19
- Interventions
- Device: Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter
- Registration Number
- NCT04478539
- Lead Sponsor
- Zan Mitrev Clinic
- 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Confirmed COVID-19 disease:
- RT-PCR
- Atypical Pneumonia; X-Ray and/or Computed Tomography
- ≥ 1 oXiris® blood purification cycle
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 patients admitted to the ICU Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter 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
- Primary Outcome Measures
Name Time Method Changes in thrombocyte counts (10^3 counts/microL) 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.Changes in the coagulation marker Fibrinogen (g/L) 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 dischargeChanges in cytokine levels of Interleukin (IL) 6, IL-8 and Tumor Necrosis Factor-α (pg/mL) 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 dischargeChanges in inflammatory markers; C-Reactive Protein (CRP) (mg/L) 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.ICU length of stay after admission (days) 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 Outcome Measures
Name Time Method Changes in the Activation Clotting Time (seconds). 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 dischargeChanges in the coagulation marker D-Dimers (ng/mL) 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 dischargeChanges in Neutrophil-to-Lymphocyte Ratio 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.
Trial Locations
- Locations (1)
Zan Mitrev Clinic
🇲🇰Skopje, North Macedonia