INTERLEUKIN 6NCT04920851
Cytokine Hemadsorption in Covid 19 Patients With Bacterial Sepsis
An observational study of INTERLEUKIN 6, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- INTERLEUKIN 6
- What is being tested?
- cytokine hemadsorption
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 20 Jul 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 23 COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test), and the criteria for patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture
Who may be able to join
- COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test),
- patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture
Who cannot join
- below 18 aged
- those who did not undergo hemoperfusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul, Küçükçekmece, 34100
ilke küpeli, 05555485632, ilkeser2004@gmail.com
About this study
Official title: Comparison of Cytokine Hemadsorption as an Immunomodulator Therapy in Covid 19 Patients With and Without Bacterial Sepsis
In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
- Conditions
- INTERLEUKIN 6
- Being tested
- cytokine hemadsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine hemadsorptionDevice
to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
| Study group | Role | What they receive |
|---|---|---|
| Covid with sepsis | Covid patient with sepsis Receives: Device: cytokine hemadsorption | |
| covid without sepsis | Covid patient without sepsis Receives: Device: cytokine hemadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 6
level of interleukin 6
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 Jun 2021 (estimated)
- Primary completion5 Jul 2021 (estimated)
- Study completion20 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for INTERLEUKIN 6Studies 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
- Retrospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İLKE KÜPELİ, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920851
- Sponsor's protocol ID
- BIRUNI 1
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Zhang W, Zhao Y, Zhang F, Wang Q, Li T, Liu Z, Wang J, Qin Y, Zhang X, Yan X, Zeng X, Zhang S. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): The Perspectives of clinical immunologists from China. Clin Immunol. 2020 May;214:108393. doi: 10.1016/j.clim.2020.108393. Epub 2020 Mar 25.
PubMed 32222466Esmaeili Vardanjani A, Ronco C, Rafiei H, Golitaleb M, Pishvaei MH, Mohammadi M. Early Hemoperfusion for Cytokine Removal May Contribute to Prevention of Intubation in Patients Infected with COVID-19. Blood Purif. 2021;50(2):257-260. doi: 10.1159/000509107. Epub 2020 Jun 26.
PubMed 32594085Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19.
PubMed 28525674
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cytokine Hemadsorption as an Immunomodulator Therapy in Covid 19 Patients With and Without Bacterial Sepsis
- ClinicalTrials.gov ID
- NCT04920851
- Acronym / sponsor ID
- BIRUNI 1
- Conditions
- INTERLEUKIN 6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jun 2021 (estimated)
- Primary completion
- 5 Jul 2021 (estimated)
- Study completion
- 20 Jul 2021 (estimated)
- First posted
- 10 Jun 2021 (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.
In this retrospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid with sepsis | – | Device: cytokine hemadsorptionCovid patient with sepsis |
| covid without sepsis | – | Device: cytokine hemadsorptionCovid patient without sepsis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 23 COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test), and the criteria for patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture
Key inclusion criteria (2 listed)
- COVID-19 patients were the available data of laboratory diagnosis of COVID-19 (a positive throat swab nucleic acid test or positive serum COVID-19 specific antibody test),
- patients with COVID-19 induced sepsis was detection of bacterial agent in blood or tracheal culture
Key exclusion criteria (2 listed)
- below 18 aged
- those who did not undergo hemoperfusion
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 |
|---|---|---|
| cytokine hemadsorptionto compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis. | Device | Covid with sepsis, covid without sepsis |
Primary outcome
interleukin 6
Time frame: 1 month
level of interleukin 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Results publication: PubMed 32222466Zhang W, Zhao Y, Zhang F, Wang Q, Li T, Liu Z, Wang J, Qin Y, Zhang X, Yan X, Zeng X, Zhang S. The use of anti-inflammatory drugs in the treatment of people with severe coronavirus disease 2019 (COVID-19): The Perspectives of clinical immunologists from China. Clin Immunol. 2020 May;214:108393. doi: 10.1016/j.clim.2020.108393. Epub 2020 Mar 25.
- Results publication: PubMed 32594085Esmaeili Vardanjani A, Ronco C, Rafiei H, Golitaleb M, Pishvaei MH, Mohammadi M. Early Hemoperfusion for Cytokine Removal May Contribute to Prevention of Intubation in Patients Infected with COVID-19. Blood Purif. 2021;50(2):257-260. doi: 10.1159/000509107. Epub 2020 Jun 26.
- Results publication: PubMed 28525674Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of INTERLEUKIN 6, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jun 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ilke küpeli (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interleukin 6 (time frame: 1 month). 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 NCT04920851, which also lists 5 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 10 Jun 2021.