Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure

COVID-19 Clinical Trial

— CYTOAID  

Official title:

Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04422626
• Other study ID #: 20802-5/2020/EÜIG
• Status: Withdrawn
• Start date: February 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Severe sepsis and septic shock are some of the leading causes of mortality in intensive care unit (ICU) admitted COVID-19 patients. The main cause of early mortality is the uncontrolled release of inflammatory mediators leading to cardiovascular failure. CytoSorb, a recently developed, highly biocompatible hemadsorption device has been tested, which 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. CYTOAID is an observational, non-interventional study to assess the effectiveness of early cytokine adsorption therapy in critically ill patients who have been admitted to the ICU because of COVID-19 infection. Data on the applied therapy on COVID-19 patients in ICU will be collected and analyzed. The patient's examination and therapy will be applied according to the current regulations at the clinics and the current professional standards. The study does not require any additional examination or intervention.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• confirmed COVID-19 infection

• ICU admission

• Mechanical ventilation due to COVID-19 pulmonary complications

• Moderate to severe acute respiratory distress syndrome (ARDS)

• CytoSorb therapy indicated by the attending medical team preferably within the first 24 hours, but no later than 48 hours after intubation

• Informed consent for data collection

Exclusion Criteria:

• Unlikely survival for 24 hours according to the attending physician

• Acute onset of hemato-oncological illness

• Patient already on ECMO

• Immunosuppression: on chronic systemic steroid therapy (>10 mg prednisolon/day); immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)

• Patients with transplanted vital organs

• Thrombocytopenia (<20,000/uL)

Related Conditions & MeSH terms

• COVID-19
• Respiratory Insufficiency
• SARS-CoV-2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy	Change in the PaO2/FiO2 ratio after CytoSorb therapy as compared to baseline	24 months
Secondary	Change in inflammatory biomarker levels during treatment	Change in white blood cell count and c-reactive protein levels during treatment compared to the baseline	24 months
Secondary	change in organ function	measured by sequential organ failure assessment (SOFA/sub-SOFA) score during treatment assessed by the treating physician	24 months
Secondary	length of stay in ICU	given in days, assessed by the treating physician	24 months
Secondary	length of hospital stay	given in days, assessed by the treating physician	24 months
Secondary	Duration of mechanical ventilation	given in days, assessed by the treating physician	24 months
Secondary	Duration of vasopressor therapy	given in days, assessed by the treating physician	24 months
Secondary	Duration of renal replacement therapy	given in days, assessed by the treating physician	24 months
Secondary	Occurrence of critical illness polyneuropathy and/or myopathy	assessed by the treating physician	24 months
Secondary	need for extracorporeal membrane oxygenation (ECMO)	Number of patients progressing to the need for ECMO assessed by the treating physician	24 months
Secondary	cost calculation	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.	24 months
Secondary	device-related adverse and serious adverse events	Number of patients with device-related adverse and serious adverse events assessed by the treating physician	24 months
Secondary	In-hospital mortality	Number of patients, who died during their hospital stay, assessed by the treating physician	24 months