Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Study Overview
Brief Summary
Direct extracorporeal removal of inflammatory mediators with various adsorbents has been suggested as a novel treatment modality for COVID-19 patients. Study determined safety, feasibility and effectiveness of clinical use of a hemoperfusion (HP) with a novel styrene- divinylbenzene copolymer (SDC) adsorbers to remove pro-inflammatory molecules from the bloodstream of COVID-19 patients.
Detailed Description
When a coronavirus is affected, the inflammatory process develops in a wide variety of organs and, in combination with a lack of oxygen, can lead to multiple organ failure. Acute respiratory distress syndrome (ARDS), seen in severe COVID-19, is characterized by shortness of breath and low blood oxygen levels. As a result, some patients may develop secondary bacterial and fungal infections. ARDS can lead to respiratory failure, which is the cause of death in 70% of COVID-19 deaths. In addition, the powerful release of cytokines by the immune system in response to viral infection and / or secondary infections can lead to symptoms of sepsis, which is the cause of death in 28% of COVID-19 cases, due to uncontrolled inflammation leading to multiple organ failure.
Most SARS-CoV patients who develop kidney failure end up dying. There is still no definitive answer to the question of why some COVID-19 patients are so severe - this may be partly due to concomitant diseases, although according to preliminary data from different countries it can be concluded that blocking the hyperactivation of immunity at the levels of IL-1 and IL- 6 may be effective in treating patients with severe coronavirus by suppressing or preventing cytokine storms.
Currently being treated COVID-19 is purely supportive. The main cause of death in seriously ill patients is acute respiratory failure. A possible reason for the development of this condition may be a cytokine storm, leading to acute decompensation of patients, which may be a possible direction of therapeutic intervention.
One of the main reasons for the high mortality rate of patients with the new coronavirus infection COVID-19 is the lack of etiotropic therapy. In this regard, pathogenetic therapy, aimed at key factors in the pathogenesis of emerging critical conditions, acquires great importance for saving the lives of patients.
Various pathogenetic treatment options are currently being discussed for the treatment of COVID-19, including selective inhibitors of various interleukins and extracorporeal cytokine elimination. So far, there is no convincing evidence of the effectiveness of the use of COVID-19 for any of them.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 81 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged 21-80,
- •Primary ICU patients (admitted to the hospital, transfer from another hospital or department less than 72 hours),
- •Positive PCR test for SARS-CoV-2,
- •PaO2 / FiO2 <300,
- •SOFA ≥ 4 with clinic of organ dysfunction.
Exclusion Criteria
- •Pregnancy,
- •The presence of signs of a bacterial infection or the addition of secondary purulent-septic complications,
- •Cancer (including blood diseases),
- •Chronic diseases in the stage of decompensation,
- •Recent or ongoing bleeding,
- •Syndrome of disseminated intravascular coagulation,
- •Thrombocytopenia,
- •Patients in terminal condition or receiving palliative care,
- •Patients for whom, for any reason, the use of anticoagulants is not safe.
Outcomes
Primary Outcomes
Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function
Time Frame: 1-120 hours
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 120 hours
Secondary Outcomes
- Effect of Efferon CT hemoperfusion on IL-6 levels(1-120 hours)
- Effect of Efferon CT hemoperfusion on Ferritin levels(1-120 hours)
- Effect of Efferon CT hemoperfusion on SOFA scores(1-120 hours)
- Effect of Efferon CT hemoperfusion on Lactate levels(1-120 hours)