Severe COVID-19 pneumonia MedDRA version: 20.0 Level: PT Classification code 10061229 Term: Lung infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: RoActemra®
Product Name: Roactemra®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Roactemra®
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration uni
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Proof of SARS-CoV2 2. Severe respiratory failure: a. ambient air SpO2 = 92% or b. Need of = 6l O2/min or c. NIV (non-invasive ventilation) or d. IMV (invasive mechanical ventilation) 3. = 18 years 4. Written informed consent obtained from the patient or legal authorized representative or investigator consilium (“Gießener Modell”) according to international guidelines and local laws; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Non-invasive or invasive mechanical ventilation = 48 hours 2. Pregnancy or breast feeding 3. Liver injury or failure (AST/ALT = 5x ULN) 4. Leukocytes 3ng/ml) 7. Acute or chronic diverticulitis 8. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone = 10mg/d, sulfasalazine or hydroxychloroquine) 9. Known active or chronic tuberculosis 10. Known active or chronic viral hepatitis 11. Known allergic reactions to tocilizumab or its ingredients 12. Life expectation of less than 1 year (independent of COVID-19) 13. Participation in any other interventional clinical trial within the last 30 days before the start of this trial 14. Simultaneous participation in other interventional trials (except for participation in COVID 19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed 15. Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception; Women can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and safety of a treatment with Tocilizumab in patients with severe COVID-19 pneumonia;Secondary Objective: Not applicable;Primary end point(s): • Ventilator free days (d) (VFD) in the first 28 days after randomisation o NIV, IMV and ECMO are defined as ventilator days o VFD=0, if the patient dies in the first 28 days after randomisation ;Timepoint(s) of evaluation of this end point: 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mortality o 28-day mortality (%) o Hospital mortality in the first 28 days (%) • Admission to intensive care unit (ICU) (%) • Days on ICU in the first 28 days (d) • IMV free days (d) in the first 28 days after randomisation o IMV and ECMO are defined as ventilator days o IMV free days =0, if the patient dies in the first 28 days • Time to successful extubation within 28 days after randomisation (d) • Renal failure (%) and renal replacement therapy (%) • Change of ventilation mode and invasiveness: o Horowitz Index (paO2/fiO2) o fiO2 on NIV/IMV o O2-level on O2 nasal cannula, O2 mask and High-flow nasal cannula o PEEP und compliance on NIV/IMV o Extracorporeal membrane oxygenation (ECMO) support • SOFA-Score • APACHE-II Score • Seven-category scale • Richmond Agitation Sedation Scale (RASS) • Glasgow Coma Scale • Laboratory (PCT, IL-6, Ferritin, D-Dimers) Until end of the study (extended follow up) • Overall survival after 12 months • QOL after 6 and 12 months • Secondary infections/ complications o Bacterial infection o Septic shock o Hepatitis / acute liver injury o Acute liver failure o Myocarditis and concomitant cardiogenic shock o Renal failure • (Serious) adverse events • Laboratory parameters Until end of the study (extended follow up): • SAEs related to IMP as per investigator’s judgment ;Timepoint(s) of evaluation of this end point: In the first 28 days after randomisation | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Universitätsklinikum Freiburg
Outcome results
None listed