NCT04920851

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

25 days

First QC Date

June 9, 2021

Last Update Submit

June 9, 2021

Conditions

INTERLEUKIN 6

Outcome Measures

Primary Outcomes (1)

  • interleukin 6

    level of interleukin 6

    1 month

Study Arms (2)

Covid with sepsis

Covid patient with sepsis

Device: cytokine hemadsorption

covid without sepsis

Covid patient without sepsis

Device: cytokine hemadsorption

Interventions

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.

Covid with sepsiscovid without sepsis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • below 18 aged
  • those who did not undergo hemoperfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Küçükçekmece, 34100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 32109013BACKGROUND

  • Yang 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.

    PMID: 32105632BACKGROUND

  • Zhang 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.

    PMID: 32222466RESULT

  • Esmaeili 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.

    PMID: 32594085RESULT

  • Houschyar 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.

    PMID: 28525674RESULT

Central Study Contacts

ilke küpeli

CONTACT

05555485632ilkeser2004@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC. PROF

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 10, 2021

Study Start

June 10, 2021

Primary Completion

July 5, 2021

Study Completion

July 20, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

TU(1)