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

Withdrawn

• Conditions: COVID-19; SARS-CoV-2

• Registration Number: NCT04422626
• Lead Sponsor: University of Pecs

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-09
• Study Start: 2022-02-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy	24 months	Change in the PaO2/FiO2 ratio after CytoSorb therapy as compared to baseline

Secondary Outcome Measures

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