Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19) (CORON-ACT)
SARS-CoV-2 Infection
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring Covid-19, Pneumonia, Tocilizumab
Eligibility Criteria
Inclusion Criteria:
I (first step):
- Admission to hospital
- Male or non-pregnant female, ≥60 years of age or ≥30 years of age plus one or more known risk factors (arterial hypertension, diabetes mellitus, coronary heart disease, heart failure, pre-existing chronic pulmonary disease)
- Confirmed SARS-CoV infection
- Radiographic evidence compatible with Covid-19 pneumonia (X-ray/CT scan, etc.)
- Signed Informed Consent Form
II (second step; indication for intervention):
- CRP ≥50mg/L plus 3 out of the following 5 criteria need to be fulfilled:
- Respiration Rate ≥25
- SpO2 <93% (on ambient air)
- PaO2 <65 mmHg
- Persistent or increasing dyspnoea as defined by a one point increase on the mMRC dyspnoea scale (over 1 hour)
- Persistent or increasing oxygen demand (over 1 hour)
Exclusion Criteria:
I (first step):
- Patients >80 years of age
- Patient included in any other interventional trial
- Indication for imminent or immediate transfer to ICU
- Treatment with TCZ (or other anti-IL-6R treatment) within 4 weeks prior to baseline
- Uncontrolled bacterial superinfection according to investigator
- History of severe allergic reaction to TCZ
- History of diverticulitis requiring antibiotic treatment or history of colon perforation
- History of primary immunodeficiency (e.g. CVID) or progressing malignancy
- History of chronic liver disease (>Child-Pugh A, or according to investigator)
II (second step; contraindication for intervention):
- Alanine transaminase/aspartate transaminase (ALT/AST) >5 times of the upper limit of normal
- Hemoglobin <80 g/L
- Leukocytes <2.0 G/L
- Absolute neutrophil count <1.0 G/L
- Platelets <50 G/L
Sites / Locations
- University Hospital Bern (Inselspital)
- Centre Hospitalier Universitaire Vaudois (CHUV)
- Ospedale Regionale di Lugano (EOC)
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Actemra
Placebo
Patients get one dose (= 8 mg/kg bodyweight, max. single dose 800 mg) Actemra® (active ingredient: TCZ) intravenously in 100 mL NaCl 0.9% after confirmation of progressive dyspnoea. Infusion time: 60 min. The procedure is repeated once if no improvement in the 8-point WHO scale is observed.
The placebo-controlled intervention is one dose (100 mL) NaCl 0.9% intravenously administered after confirmation of progressive dyspnoea. Infusion time: 60 min. The procedure is repeated once if no improvement in the 8-point WHO scale is observed.