- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04422626
Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure (CYTOAID)
Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Contact
- Name: Péter Hegyi, MD, PhD, DSc
- Phone Number: +36703751031
- Email: hegyi2009@gmail.com
Study Contact Backup
- Name: Zsolt Molnár, MD, PhD, Dsc
- Email: zsoltmolna@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
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
|
24 months
|
length of stay in ICU
Time Frame: 24 months
|
given in days, assessed by the treating physician
|
24 months
|
length of hospital stay
Time Frame: 24 months
|
given in days, assessed by the treating physician
|
24 months
|
Duration of mechanical ventilation
Time Frame: 24 months
|
given in days, assessed by the treating physician
|
24 months
|
Duration of vasopressor therapy
Time Frame: 24 months
|
given in days, assessed by the treating physician
|
24 months
|
Duration of renal replacement therapy
Time Frame: 24 months
|
given in days, assessed by the treating physician
|
24 months
|
Occurrence of critical illness polyneuropathy and/or myopathy
Time Frame: 24 months
|
assessed by the treating physician
|
24 months
|
need for extracorporeal membrane oxygenation (ECMO)
Time Frame: 24 months
|
Number of patients progressing to the need for ECMO assessed by the treating physician
|
24 months
|
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.
|
24 months
|
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
|
24 months
|
In-hospital mortality
Time Frame: 24 months
|
Number of patients, who died during their hospital stay, assessed by the treating physician
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20802-5/2020/EÜIG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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