Covid19NCT04518969
Determination of the Hemoadsorption Impact as Adjunctive Treatment Upon the Support Therapy of COVID-19
A study testing CytoSorb in people with Covid19, run by Dr David DE BELS at 1 site in Belgium.
Trial summary
A) Comparing the % of change in each clearances of pro-, and anti-inflammatory mediators (cytokine, chemokines and complement) in the COVID-19 patients treated with CytoSorb as compared to the same patient population who do not receive blood purification treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 3 May 2020to 16 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology-Patient COVID type L (Criteria Gattinoni -CT Scan )
Who cannot join
- Patient COVID type H ( Gattinoni's Criteria -CT Scan )
- Patient's refusal or refusal of his legal representative
- HIV + AIDS
- Short life Expectancy
- Patients over 80 years of age.
- Patients under ECMO or ECCO2R
- Immunosuppression (steroids, chemotherapy…)
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Cytokine Clearances of Pro-, and Anti-inflammatory Mediators, Chemokines and Complement in the COVID-19 Patients Treated With CytoSorb as Compared to the Same Patient Population Who do Not Receive Blood Purification Treatment
- Comparing the % of change in each clearances of pro-, and anti-inflammatory mediators (cytokine, chemokines and complement) in the COVID-19 patients treated with CytoSorb as compared to the same patient population who do not receive blood purification treatment.
- Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.
Read the detailed description
Coronavirus disease-19 (COVID-19) has emerged as a serious pandemic recently, with high mortality especially in those patients who went on to develop acute respiratory failure (around 50%), and especially in those who also developed acute kidney injury (AKI) (80%). Extracorporeal cytokine removal has been recommended by international expert. Two technical approaches have been studied one from Jafron® HA380 (Jafron Biomedical, Zhuhai, Chine) and Cytosorb® (Cytosorbents Corporation, NJ, USA). Basically, it is a single -use sorbent technology that can be used together with an hemofiltration circuit in CVVHD mode only. The cartridge is made of adsorptive porous polymeric beats that represent all together an active surface of 60,000 square meters.The cut-off of these cartridge is about 60,000 daltons and all the cytokines smaller can easily removed by the cartridge especially in the blood stream. The elimination percentage goes from 4 to 30 % with the CytoSorb® and remain steady for the first 6 to 12 hours. The full elimination from the blood stream vary amongst cytokines. It is about 28 % for IL-6- (p = 0.006) and somewhat less for TNF-alpha (8,5%, p = 0.13). Currently, there is no available randomized controlled trial that assess morbidity and mortality in ARDS secondary to COVID infections. There is one pilot study looking at 20 patients with early (<24 h) onset of septic shock of medical origin, on mechanical ventilation, norepinephrine>10 μg/min, procalcitonin (PCT) > 3 ng/mL without the need for renal replacement therapy were randomized into CytoSorb (n = 10) and Control groups (n = 10). CytoSorb therapy lasted for 24 h. This was the first trial to investigate the effects of early extracorporeal cytokine adsorption treatment in septic shock applied without renal replacement therapy. It was found to be safe with significant effects on norepinephrine requirements, PCT and Big-endothelin-1 concentrations compared to controls.
Actually, other studies are only case report series upon other pulmonary infections than COVID 19.The sorbent chose is the CytoSorb ® it is easier to install, has a CEE approval and his temporally approval by the FDA for the time of the pandemic.
The features of acute hypoxemic respiratory failure in COVID-19 show two fundamentally different phenotypes. One is the L-type: Low elastance; Low ventilation-to-perfusion ratio; Low lung weight; Low lung recruitability. The H-type is characterized by the opposite features. The latter is more similar to the classical ARDS and being investigated by several studies. However, little is known about pathogenesis of the L-type, which can cause hypoxemia to the same degree as the H-type. Even the pathophysiology is yet to be discovered, however, vasoplegia is considered one of the major factors leading to severe right-to-left shunt.
It is postulated that cytokines , chemokines play a crucial role in the pathogenesis, but it has not been investigated yet. Therefore we have chosen the clearance of these substances as our primary endpoint. Usually, CytoSorb is attached to a CRRT circuit which has to run in a CVVHD mode only. In some circumstances CytoSorb might be attached to the ECMO device. In addition to cytokines complements may also play a major role in the pathophysiology of the COVID 19. Therefore, we decided to investigate whether early treatment with blood purification could exert any effects on the cytokine and complement profile and oxygenation in these patients. Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.
- Conditions
- Covid19
- Being tested
- CytoSorb
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
Also called CRRT
CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect.
First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours.
After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard medical therapy (ie: control group) : Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed…… |
| Cytosorb | Experimental | CytoSorb therapy (ie: study group): Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed…… Plus patients will be on CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect.
First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours.
After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist. Receives: Device: CytoSorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing % of change in cytokine's clearances of pro et anti -inflammatory types
comparing the % of change in cytokine's clearances of pro et anti -inflammatory types, as well chemokines and complement pathway between a control population and a treated population with sorbent technology.
Measured: Day 1 to 5
Secondary outcomes (5)
Evaluation of the impact upon the survival rate at 28 and 90 days.
Evaluation of the impact upon the survival rate at 28 and 90 days.Beside mortality, morbidity will be evaluate (free ventilatory days, ICU length of stay, shock free days , need of ECMO and secondary bacterial infections.
Measured: Day 28 and Day 90
Chemokine kinetics
Chemokine kinetics over time and compared to the control group Chemkine kinetics between blood and lung [time frame at day 1,3 and 5]
Measured: Day 1 to 5
Cytokine kinetics
Cytokine kinetics in COVID critically ill patients over time and compared to the control group. [Time Frame: Day 1 to 5] Cytokine kinetics over time and compared to the control group. Chemkine kinetics between blood and lung [time frame at day 1,3 and 5]
Measured: Day 1 to 5
Complement pathway kinetics
Complement pathway kinetics in COVID critically ill patients. [Time Frame: Day 1 to 5] Complement pathway kinetics over time and compared to the control group Complement pathway kinetics between blood and lung [time frame at day 1,3 and 5]
Measured: Day 1 to 5
PaO2/FiO2 ratio
Evaluation of PaO2/FiO2 ratio evolution during ICU stay
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start3 May 2020
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr David DE BELS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr David DE BELS, Brugmann University Hospital
- Investigators
- Patrick Honore, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518969
- Sponsor's protocol ID
- BrugmannUH 1066
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.
PubMed 32204907Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Respir Med. 2020 Mar;8(3):240-241. doi: 10.1016/S2213-2600(20)30060-6. Epub 2020 Feb 6. No abstract available.
PubMed 32035509Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. doi: 10.1097/01.CCM.0000291646.34815.BB.
PubMed 18090355Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.
PubMed 30448517Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
PubMed 32291463Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.
PubMed 12147537Kellum JA, Kong L, Fink MP, Weissfeld LA, Yealy DM, Pinsky MR, Fine J, Krichevsky A, Delude RL, Angus DC; GenIMS Investigators. Understanding the inflammatory cytokine response in pneumonia and sepsis: results of the Genetic and Inflammatory Markers of Sepsis (GenIMS) Study. Arch Intern Med. 2007 Aug 13-27;167(15):1655-63. doi: 10.1001/archinte.167.15.1655.
PubMed 17698689Honore PM, Hoste E, Molnar Z, Jacobs R, Joannes-Boyau O, Malbrain MLNG, Forni LG. Cytokine removal in human septic shock: Where are we and where are we going? Ann Intensive Care. 2019 May 14;9(1):56. doi: 10.1186/s13613-019-0530-y.
PubMed 31089920Cavaillon JM, Munoz C, Fitting C, Misset B, Carlet J. Circulating cytokines: the tip of the iceberg? Circ Shock. 1992 Oct;38(2):145-52.
PubMed 1423923Akil A, Ziegeler S, Reichelt J, Rehers S, Abdalla O, Semik M, Fischer S. Combined Use of CytoSorb and ECMO in Patients with Severe Pneumogenic Sepsis. Thorac Cardiovasc Surg. 2021 Apr;69(3):246-251. doi: 10.1055/s-0040-1708479. Epub 2020 Apr 6.
PubMed 32252114Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
PubMed 30301856Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.
PubMed 21918497
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Cytokine Clearances of Pro-, and Anti-inflammatory Mediators, Chemokines and Complement in the COVID-19 Patients Treated With CytoSorb as Compared to the Same Patient Population Who do Not Receive Blood Purification Treatment
- ClinicalTrials.gov ID
- NCT04518969
- Acronym / sponsor ID
- BrugmannUH 1066
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr David DE BELSUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 19 Aug 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.
- Comparing the % of change in each clearances of pro-, and anti-inflammatory mediators (cytokine, chemokines and complement) in the COVID-19 patients treated with CytoSorb as compared to the same patient population who do not receive blood purification treatment.
- Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.
Detailed description
Coronavirus disease-19 (COVID-19) has emerged as a serious pandemic recently, with high mortality especially in those patients who went on to develop acute respiratory failure (around 50%), and especially in those who also developed acute kidney injury (AKI) (80%). Extracorporeal cytokine removal has been recommended by international expert. Two technical approaches have been studied one from Jafron® HA380 (Jafron Biomedical, Zhuhai, Chine) and Cytosorb® (Cytosorbents Corporation, NJ, USA). Basically, it is a single -use sorbent technology that can be used together with an hemofiltration circuit in CVVHD mode only. The cartridge is made of adsorptive porous polymeric beats that represent all together an active surface of 60,000 square meters.The cut-off of these cartridge is about 60,000 daltons and all the cytokines smaller can easily removed by the cartridge especially in the blood stream. The elimination percentage goes from 4 to 30 % with the CytoSorb® and remain steady for the first 6 to 12 hours. The full elimination from the blood stream vary amongst cytokines. It is about 28 % for IL-6- (p = 0.006) and somewhat less for TNF-alpha (8,5%, p = 0.13). Currently, there is no available randomized controlled trial that assess morbidity and mortality in ARDS secondary to COVID infections. There is one pilot study looking at 20 patients with early (<24 h) onset of septic shock of medical origin, on mechanical ventilation, norepinephrine>10 μg/min, procalcitonin (PCT) > 3 ng/mL without the need for renal replacement therapy were randomized into CytoSorb (n = 10) and Control groups (n = 10). CytoSorb therapy lasted for 24 h. This was the first trial to investigate the effects of early extracorporeal cytokine adsorption treatment in septic shock applied without renal replacement therapy. It was found to be safe with significant effects on norepinephrine requirements, PCT and Big-endothelin-1 concentrations compared to controls.
Actually, other studies are only case report series upon other pulmonary infections than COVID 19.The sorbent chose is the CytoSorb ® it is easier to install, has a CEE approval and his temporally approval by the FDA for the time of the pandemic.
The features of acute hypoxemic respiratory failure in COVID-19 show two fundamentally different phenotypes. One is the L-type: Low elastance; Low ventilation-to-perfusion ratio; Low lung weight; Low lung recruitability. The H-type is characterized by the opposite features. The latter is more similar to the classical ARDS and being investigated by several studies. However, little is known about pathogenesis of the L-type, which can cause hypoxemia to the same degree as the H-type. Even the pathophysiology is yet to be discovered, however, vasoplegia is considered one of the major factors leading to severe right-to-left shunt.
It is postulated that cytokines , chemokines play a crucial role in the pathogenesis, but it has not been investigated yet. Therefore we have chosen the clearance of these substances as our primary endpoint. Usually, CytoSorb is attached to a CRRT circuit which has to run in a CVVHD mode only. In some circumstances CytoSorb might be attached to the ECMO device. In addition to cytokines complements may also play a major role in the pathophysiology of the COVID 19. Therefore, we decided to investigate whether early treatment with blood purification could exert any effects on the cytokine and complement profile and oxygenation in these patients. Testing the Cytokinetic model by measuring cytokines in the blood stream and in the BAL to see if you can create a reverse gradient allowing a massive passage of leucocyte from the blood toward the infected lungs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard medical therapy (ie: control group) : Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed…… |
| Cytosorb | Experimental | Device: CytoSorbCytoSorb therapy (ie: study group): Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology N =12 -Mechanical ventilation, prone position if needed,fluid challenge if needed , vasopressors if needed, inotropic support in needed…… Plus patients will be on CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect. First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours. After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult intensive care patient admit in acute respiratory distress needing intubation with suspicion of under the CT Scan of Covid 19 confirmed by positive antigen or PCR technology-Patient COVID type L (Criteria Gattinoni -CT Scan )
Key exclusion criteria (8 listed)
- Patient COVID type H ( Gattinoni's Criteria -CT Scan )
- Patient's refusal or refusal of his legal representative
- HIV + AIDS
- Short life Expectancy
- Patients over 80 years of age.
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 |
|---|---|---|
| CytoSorbAlso: CRRTCRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect. First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours. After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist. | Device | Cytosorb |
Primary outcome
comparing % of change in cytokine's clearances of pro et anti -inflammatory types
Time frame: Day 1 to 5
comparing the % of change in cytokine's clearances of pro et anti -inflammatory types, as well chemokines and complement pathway between a control population and a treated population with sorbent technology.
5 secondary outcomes
Evaluation of the impact upon the survival rate at 28 and 90 days.
Time frame: Day 28 and Day 90
Chemokine kinetics
Time frame: Day 1 to 5
Cytokine kinetics
Time frame: Day 1 to 5
Complement pathway kinetics
Time frame: Day 1 to 5
PaO2/FiO2 ratio
Time frame: Up to 90 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 4 Mar 2022.
- Background: PubMed 32204907Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.
- Background: PubMed 32035509Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Respir Med. 2020 Mar;8(3):240-241. doi: 10.1016/S2213-2600(20)30060-6. Epub 2020 Feb 6. No abstract available.
- Background: PubMed 18090355Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. doi: 10.1097/01.CCM.0000291646.34815.BB.
- Background: PubMed 30448517Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.
- Background: PubMed 32291463Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.
- Background: PubMed 12147537Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.
- Background: PubMed 17698689Kellum JA, Kong L, Fink MP, Weissfeld LA, Yealy DM, Pinsky MR, Fine J, Krichevsky A, Delude RL, Angus DC; GenIMS Investigators. Understanding the inflammatory cytokine response in pneumonia and sepsis: results of the Genetic and Inflammatory Markers of Sepsis (GenIMS) Study. Arch Intern Med. 2007 Aug 13-27;167(15):1655-63. doi: 10.1001/archinte.167.15.1655.
- Background: PubMed 31089920Honore PM, Hoste E, Molnar Z, Jacobs R, Joannes-Boyau O, Malbrain MLNG, Forni LG. Cytokine removal in human septic shock: Where are we and where are we going? Ann Intensive Care. 2019 May 14;9(1):56. doi: 10.1186/s13613-019-0530-y.
- Background: PubMed 1423923Cavaillon JM, Munoz C, Fitting C, Misset B, Carlet J. Circulating cytokines: the tip of the iceberg? Circ Shock. 1992 Oct;38(2):145-52.
- Background: PubMed 32252114Akil A, Ziegeler S, Reichelt J, Rehers S, Abdalla O, Semik M, Fischer S. Combined Use of CytoSorb and ECMO in Patients with Severe Pneumogenic Sepsis. Thorac Cardiovasc Surg. 2021 Apr;69(3):246-251. doi: 10.1055/s-0040-1708479. Epub 2020 Apr 6.
- Background: PubMed 30301856Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5):e01753-18. doi: 10.1128/mBio.01753-18.
- Background: PubMed 21918497Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmele T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis. Kidney Int. 2012 Feb;81(4):363-9. doi: 10.1038/ki.2011.320. Epub 2011 Sep 14.
- 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.
Patrick Honore, MD principal investigator
CHU Brugmann
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 in people with Covid19, run by Dr David DE BELS at 1 site in Belgium.
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 1 inclusion and 8 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 4 Mar 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 Belgium. 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?
comparing % of change in cytokine's clearances of pro et anti -inflammatory types (time frame: Day 1 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518969, which also lists 12 linked publications.
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 4 Mar 2022.