SARS-CoV-2CYTOAIDNCT04422626
Data Analysis of the Cytokine Adsorption Treatment on Coronavirus Disease-19 (COVID-19) Patients With Respiratory Failure
An observational study of SARS-CoV-2 and COVID-19, run by University of Pecs.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2, COVID-19
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients admitted to ICUs requiring mechanical ventilation with proven COVID-19 infection and treated with CytoSorb.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19
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.
Read the 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.
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- CytoSorb, COVID-19, acute respiratory failure, cytokine, Intensive care unit, Sars-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (12)
Change in inflammatory biomarker levels during treatment
Change in white blood cell count and c-reactive protein levels during treatment compared to the baseline
Measured: 24 months
change in organ function
measured by sequential organ failure assessment (SOFA/sub-SOFA) score during treatment assessed by the treating physician
Measured: 24 months
length of stay in ICU
given in days, assessed by the treating physician
Measured: 24 months
length of hospital stay
given in days, assessed by the treating physician
Measured: 24 months
Duration of mechanical ventilation
given in days, assessed by the treating physician
Measured: 24 months
Duration of vasopressor therapy
given in days, assessed by the treating physician
Measured: 24 months
Duration of renal replacement therapy
given in days, assessed by the treating physician
Measured: 24 months
Occurrence of critical illness polyneuropathy and/or myopathy
assessed by the treating physician
Measured: 24 months
need for extracorporeal membrane oxygenation (ECMO)
Number of patients progressing to the need for ECMO assessed by the treating physician
Measured: 24 months
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.
Measured: 24 months
device-related adverse and serious adverse events
Number of patients with device-related adverse and serious adverse events assessed by the treating physician
Measured: 24 months
In-hospital mortality
Number of patients, who died during their hospital stay, assessed by the treating physician
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Feb 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: The human resources required to start enrollment were not available anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Péter Hegyi, MD, PhD, DSc, Study chair, Insitute for Translational Medicine, University of Pécs, HU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422626
- Sponsor's protocol ID
- 20802-5/2020/EÜIG
- Acronym
- CYTOAID
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection on the Application of Cytokine Adsorption Therapy on Patients With Acute Respiratory Failure Caused by COVID-19
- ClinicalTrials.gov ID
- NCT04422626
- Acronym / sponsor ID
- CYTOAID / 20802-5/2020/EÜIG
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- CytoSorb, COVID-19, acute respiratory failure, cytokine, Intensive care unit, Sars-CoV-2
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The human resources required to start enrollment were not available anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to ICUs requiring mechanical ventilation with proven COVID-19 infection and treated with CytoSorb.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
Change in inflammatory biomarker levels during treatment
Time frame: 24 months
change in organ function
Time frame: 24 months
length of stay in ICU
Time frame: 24 months
length of hospital stay
Time frame: 24 months
Duration of mechanical ventilation
Time frame: 24 months
Duration of vasopressor therapy
Time frame: 24 months
Duration of renal replacement therapy
Time frame: 24 months
Occurrence of critical illness polyneuropathy and/or myopathy
Time frame: 24 months
need for extracorporeal membrane oxygenation (ECMO)
Time frame: 24 months
cost calculation
Time frame: 24 months
device-related adverse and serious adverse events
Time frame: 24 months
In-hospital mortality
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Péter Hegyi, MD, PhD, DSc study chair
Insitute for Translational Medicine, University of Pécs, HU
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19, run by University of Pecs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio after CytoSorb therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.