Trial document




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  DRKS00021238

Trial Description

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Title

A prospective, randomized, double blinded placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia

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Trial Acronym

TOC-COVID

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study the efficacy and safety of an treatment with tocilizumab will be analysed in patients with severe COVID-19 pneumonia.

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Brief Summary in Scientific Language

Evaluation of efficacy and safety of a tocilizumab treatment in patients with severe COVID-19 pneumonia.

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

Yes

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Description IPD sharing plan:

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Organizational Data

  •   DRKS00021238
  •   2020/04/22
  •   [---]*
  •   yes
  •   Approved
  •   203/20 (FF-MC), Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2020-001408-41 
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Health Condition or Problem studied

  •   U07.1 -  Emergency use of U07.1
  •   COVID-19, SARS-CoV2, Corona-Virus
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Interventions/Observational Groups

  •   Intervention:
    Tocilizumab - Application of 8mg/kg body weight (BW) Tocilizumab i.v. once immediately after randomisation (12 mg/kg for patients with <30kg BW; total dose should not exceed 800 mg) + Conventional treatment
  •   Control: Placebo i.v. once immediately after randomisation + Conventional treatment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   Yes
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Primary Outcome

ventilator free days (in the first 28 days)

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Secondary Outcome

Mortality
- 28-day mortality (%)
- hospital mortality (%)
Admission to ICU (%)
Days on ICU (d)
Ventilator freee days (without NIV) (d)
Renal failure and dialysis (%)
Change of ventilation mode and invasivity
- Horrowitz Index (PaO2/FiO2)
- fiO2 on NIV/IMV
- fiO2 on O2-Maske/Highflow-Therapie
- PEEP und Compliance on NIV/IMV
SOFA-Score
Seven-Scale Category
Treatment safety

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/05/03
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Proof of SARS-CoV2
Severe respiratory failure
- ambient air SpO2 ≤ 92% or
- Need of ≥ 6l O2/min or
- NIV or IMV

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Exclusion Criteria

1. Invasvie or non-invasive mechanical ventilation ≥ 48 hours
2. pregnancy or lactation period
3. Liver injury or failure (AST/ALT ≥ 5x above normal)
4. Leucocytes < 2 × 10^3/µl
5. Thrombocytes < 50 × 10^3/μl
6. severe bacterial infection (PCT > 3ng/ml)
7. rheumatoid arthritis
8. Immunosuppressive therapy
9. Known tuberculosis
10. Known active or chronic viral hepatitis
11. Allergic reactions to Tocilizumab or its ingredients
12. Life expaction of less then 1 year (independent of Covid-19)

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Medizinische Klinik IIIAlbert-Ludwigs-Universität Freiburg
    • Mr.  PD Dr.  Tobias  Wengenmayer 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
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    • Medizinische Klinik IIIAlbert-Ludwigs-Universität Freiburg
    • Mr.  PD Dr.  Tobias  Wengenmayer 
    • Hugstetter Str. 55
    • 79106  Freiburg i. Br.
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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