Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure (CYTOAID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04422626|
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
|Condition or disease|
In the early phase of sepsis, the activation of innate immunity plays a significant role. Immune cells enhance the production of pro-inflammatory mediators. These pro-inflammatory mediators are responsible for the development of immune response and the intensification of the inflammatory processes. To counteract this, anti-inflammatory mediators limit and alleviate inflammation. Critically ill septic patients with higher levels of both anti- and proinflammatory mediators are at higher risk for death. The main cause for early mortality is the uncontrolled release of inflammatory mediators leading to cardiovascular failure, while in the late phase of the disease, secondary infections and the subsequent multiorgan failure dominate due to the exhaustion of the immune functions and the subsequent insufficient protective mechanisms. Therefore, it has been suggested that the outcomes of severe sepsis can be improved by attenuating the inflammatory processes. A recently developed, highly biocompatible hemadsorption device has been tested that can selectively remove inflammatory mediators from the circulation. This device is currently commercially available, and in Europe, it has been approved for clinical use. Based on experience to date, this adsorption technique may influence the immune function; removing inflammatory mediators from the blood may improve organ functions and even increase the chances of survival.
During the study, data will be collected exclusively; the application of CytoSorb therapy will be considered by the current physician always on an individual basis. Data will be recorded during hospitalization (using the documentations of the ICU) and immediately after discharge.
This study is suitable for recording every step of medical care from the diagnosis of SARS-CoV-2 infection. To investigate the biomarkers and the genetic background that potentially play a role in the infection, biological samples will be also collected - by already indicated interventions during standard care, i.e. without additional intervention.
This study aims to describe cytokine adsorption therapy (CytoSorb) in general and to detect its most important features. The study would also like to assess the safety and cost-effectiveness of the therapy, evaluate specific interventions required during the treatment, and to assess the outcomes of the disease. This study can provide important data and expand our knowledge about COVID-19 and its treatment, as well as improve the outcomes of the disease.
|Study Type :||Observational|
|Estimated Enrollment :||42 participants|
|Official Title:||Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Critically ill COVID-19 patients, who receive CytoSorb therapy
Patients in ICU due to critical COVID-19 infection, who receive early (within the first 24 hours, but no later than 48 hours after intubation) CytoSorb therapy on consultant's discretion.
- Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy [ Time Frame: 24 months ]Change in the PaO2/FiO2 ratio after CytoSorb therapy as compared to baseline
- Change in inflammatory biomarker levels during treatment [ Time Frame: 24 months ]Change in white blood cell count and c-reactive protein levels during treatment compared to the baseline
- change in organ function [ Time Frame: 24 months ]measured by sequential organ failure assessment (SOFA/sub-SOFA) score during treatment assessed by the treating physician
- length of stay in ICU [ Time Frame: 24 months ]given in days, assessed by the treating physician
- length of hospital stay [ Time Frame: 24 months ]given in days, assessed by the treating physician
- Duration of mechanical ventilation [ Time Frame: 24 months ]given in days, assessed by the treating physician
- Duration of vasopressor therapy [ Time Frame: 24 months ]given in days, assessed by the treating physician
- Duration of renal replacement therapy [ Time Frame: 24 months ]given in days, assessed by the treating physician
- Occurrence of critical illness polyneuropathy and/or myopathy [ Time Frame: 24 months ]assessed by the treating physician
- need for extracorporeal membrane oxygenation (ECMO) [ Time Frame: 24 months ]Number of patients progressing to the need for ECMO assessed by the treating physician
- cost calculation [ Time Frame: 24 months ]The financial demand of the treatment of COVID-19 infection spent on each patient will be calculated by a healthcare economist after the trial is completed.
- device-related adverse and serious adverse events [ Time Frame: 24 months ]Number of patients with device-related adverse and serious adverse events assessed by the treating physician
- In-hospital mortality [ Time Frame: 24 months ]Number of patients, who died during their hospital stay, assessed by the treating physician
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422626
|Contact: Péter Hegyi, MD, PhD, Dscfirstname.lastname@example.org|
|Contact: Zsolt Molnár, MD, PhD, Dscemail@example.com|
|Study Chair:||Péter Hegyi, MD, PhD, DSc||Insitute for Translational Medicine, University of Pécs, HU|