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

Completed
COVID19

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

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).

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
North Macedonia
Locations

Zan Mitrev Clinic
Skopje, North Macedonia

Zan Mitrev Clinic
NCT Number
Keywords
SARS-CoV-2
Cytokine storm
Interleukin 6
hypercoagulability
Fibrinogen
D-dimer
MeSH Terms
COVID-19