Trial document




drksid header

  DRKS00021447

Trial Description

start of 1:1-Block title

Title

CytoResc - CytoSorb Rescue for COVID-19 Cytokine Storm

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CytoResc

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The novel coronavirus SARS-CoV-2 and the resulting lung disease COVID-19 are pushing healthcare systems around the world to the limits of their capacity. About 14 % of infected patients have a severe clinical course. 5 % require treatment in an intensive care unit. Several observations suggest that a cytokine storm syndrome, as an expression of the excessive immune response, can lead to acute decompensation of patients, which could be a possible therapeutic approach for specific treatments. So far, the administration of glucocorticoids, tocilizumab (anti-IL6 receptor antibody) and extracorporeal elimination are discussed for treatment. There is no evidence for any of them. In addition, there is a concern that both glucocorticoids and tocilizumab could be harmful due to immunosuppression. CytoSorb is an adsorber that is able to remove cytokines and other toxins from the blood. It is a certified medical device which is already used in clinical practice and known to be safe. Data concerning clinical effectiveness is inconsistent. Nevertheless, it is already broadly used in clinical practice, especially in sepsis patients and increasingly also in COVID-19 patients, despite insufficient evidence. The aim of this study is to investigate the effect of the application of CytoSorb for the elimination of cytokines in critically ill patients with COVID-19.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

SARS-CoV-2 and COVID-19 are pushing health care systems around the world to the limits of their capacity. Approximately 14 % of the infected patients present with a serious clinical course; 5% need ICU-treatment. As so far, only supportive treatment is known, a large number of different treatments in compassionate use can be expected. Main reason of death in critically ill patients is acute respiratory failure. There are several observations indicating a cytokine storm leading to acute decompensation of patients which might be a possible option for therapeutic intervention. Several possible treatment options are discussed, including streroids, Tocilizumab (an anti-IL6-receptor antibody) as well as extracorporeal elimination. So far, there is no evidence for any of them. On the contrary, steroids and Tocilizumab may even be harmful due to immunosuppression. CytoSorb (Cytosorbents, Corporation, New Jersey, USA) is an adsorber containing hemocompatible, porous polymer chains capable of eliminating cytokines and other toxins of medium molecular weight from the blood. Despite of the inconsistent data on clinical efficacy, it is already beeing used in clinical routine especially in sepsis patients. Recent data show the successfull use of CytoSorb in CAR-T-associated cytokinestorm. Apart from the invasiveness of the procedure (there is the need for a large central venous access which most critical patients have anyway), the method is known to be safe. To build a prospective reliable evidence (also including negative results) we are planning to do a pragmatic prospective, multicenter, randomized, open-label pilotstudy. Aim of this study is to investigate the effect of the use of CytoSorb in order to eliminate cytokines in critically ill patients with COVID-19.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

All individual patient data on which the results of the publication are based will be made available in anonymised form to scientists who present a reasonable analysis plan. The aim is to make the scientific findings available for other research projects. Data requests should be addressed to: torsten.slowinski@charite.de. For data access, the applicant must sign a data access authorization. Furthermore, the study protocol, the statistical analysis plan, the patient information and the patient consent form will be made available to all interested persons. These documents are available on an external website for 5 years.
The data will be made available for a total of 3 months up to a maximum of 5 years.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00021447
  •   2020/04/27
  •   [---]*
  •   yes
  •   Approved
  •   EA1/069/20, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1250-8875 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   CytoSorb treatment initiated within 24 hours after fullfilling the inclusion criteria persued for 3-7 days
  •   Standard of care without CytoSorb treatment
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IIb
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

time to resolution of vasoplegic shock (defined as no need for vasopressors for at least 8 hours in order to sustain a MAD ≥ 65mmHg) in days

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

7 day mortality after fulfilling the inclusion criteria, mortality until hospital discharge, IL-6 measurement on day 1 and 3, need for mechanical ventilation, duration of mechanical ventilation, duration of ICU-stay, catecholamine dose on day 1/2/3 after start of CytoSorb, acute kidney injury

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/05/01
  •   100
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Males or females aged 18-80, Positive PCR test for SARS-CoV-2, Vasoplegic shock (Noradrenalin > 0.2 µg/min/kg (aiming MAD ≥ 65mmHg), CRP > 100 mg/l, PCT < 2 ng/l

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients receiving Tocilizumab (anti-IL6-receptor antibody), Patients not applicable for anticoagulation (if Heparin is not applicable, local anticoagulation with citrate or systemic Argatroban can be used, severe thrombocytopenia < 20.000/μl is a contraindication), pregnancy, bacterial infection

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité Campus Virchow-Klinikum
    • Mr.  PD Dr.  Philipp  Enghardt 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité Campus Virchow-Klinikum
    • Mr.  Dr.  Torsten  Slowinski 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.