Extracorporeal Blood Purification as a Treatment Modality for COVID-19

Zan Mitrev Clinic

Status: Completed

Conditions: Covid19

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

Study type: Observational

Funder types: Other

Identifiers

NCT04478539

EBPZ.357

Details and patient eligibility

About

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.

Full 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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

COVID-19 patients admitted to the ICU

Description:

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

Treatment:

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