COVID-19CYTOCOV-19NCT04344080
Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
A study testing CytoSorb-Therapy in people with COVID-19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- CytoSorb-Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 28 Apr 2021
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed COVID-19 disease
- refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
- IL6 ≥ 500 ng/l
- Indication for CRRT or ECMO
Who cannot join
- Liver cirrhosis Child Pugh C
- "do not resuscitate"-order
- expected survival due to comorbidities < 14 days
- pregnancy or breastfeeding
- participation in another interventional trial
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.
- Conditions
- COVID-19
- Being tested
- CytoSorb-Therapy
- Keywords
- critically ill, intensive care medicine, CytoSorb, hemoadsorption
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb-TherapyDevice
Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb-Therapy | Active comparator | Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber Receives: Device: CytoSorb-Therapy |
| Standard of care | No intervention | Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group
Measured: 24 hours
Secondary outcomes (13)
Change in organ dysfunction
Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient's ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.
Measured: 10 days
Lactate clearance
Improving lactate clearance by lowering serum lactate levels
Measured: 10 days
Renal replacement therapy
Time with need for renal replacement therapy
Measured: 10 days
Extracorporeal Membrane Oxygenation
Time with Need for Extracorporeal Membrane Oxygenation
Measured: 10 days
ICU length of stay
ICU length of stay
Measured: 90 days
Time on mechanical ventilation
Time on mechanical ventilation
Measured: 10 days
Cumulative catecholamine dose
Cumulative catecholamine dose
Measured: 10 days
Overall and ICU mortality
Overall and ICU mortality
Measured: 90 days
Change of plasma Interleukin-6 (IL6) level
Change of plasma Interleukin-6 (IL6) level
Measured: 10 days
Change of plasma Interleukin-10 (IL10) level
Change of plasma Interleukin-10 (IL10) level
Measured: 10 days
Change of plasma Procalcitonin (PCT) level
Change of plasma Procalcitonin (PCT) level
Measured: 10 days
Change of HLA-DR level
Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
Measured: 10 days
Change of TNF alpha level after ex-vivo stimulation
Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Apr 2020
- Primary completion10 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Kluge, MD, Principal investigator, University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344080
- Sponsor's protocol ID
- CYTOCOV-19
- Other IDs
- U1111-1250-2078, DRKS00021199
- Acronym
- CYTOCOV-19
- Status last verified
- Sep 2022
- First submitted
- 9 Apr 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04344080
- Acronym / sponsor ID
- CYTOCOV-19 / CYTOCOV-19
- Conditions
- COVID-19
- Keywords
- critically ill, intensive care medicine, CytoSorb, hemoadsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 14 Apr 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.
This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytoSorb-Therapy | Active comparator | Device: CytoSorb-TherapyTherapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care in Addition with hemoadsorption using CytoSorb-Adsorber |
| Standard of care | No intervention | –Therapy of COVID-19 with need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) using standard of care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed COVID-19 disease
- refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
- IL6 ≥ 500 ng/l
- Indication for CRRT or ECMO
Key exclusion criteria (5 listed)
- Liver cirrhosis Child Pugh C
- "do not resuscitate"-order
- expected survival due to comorbidities < 14 days
- pregnancy or breastfeeding
- participation in another interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb-TherapyAdditional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation) | Device | CytoSorb-Therapy |
Primary outcome
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours
Time frame: 24 hours
Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group
13 secondary outcomes
Change in organ dysfunction
Time frame: 10 days
Lactate clearance
Time frame: 10 days
Renal replacement therapy
Time frame: 10 days
Extracorporeal Membrane Oxygenation
Time frame: 10 days
ICU length of stay
Time frame: 90 days
Time on mechanical ventilation
Time frame: 10 days
Cumulative catecholamine dose
Time frame: 10 days
Overall and ICU mortality
Time frame: 90 days
Change of plasma Interleukin-6 (IL6) level
Time frame: 10 days
Change of plasma Interleukin-10 (IL10) level
Time frame: 10 days
Change of plasma Procalcitonin (PCT) level
Time frame: 10 days
Change of HLA-DR level
Time frame: 10 days
Change of TNF alpha level after ex-vivo stimulation
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Published trial on PubMed.govLink provided by the sponsor.
- 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.
Stefan Kluge, MD principal investigator
University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb-Therapy in people with COVID-19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours (time frame: 24 hours). 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 21 Sep 2022.