Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
Drug: iv Tocillizumab (TCZ)
Participants are randomized (2:1) to receive TCZ or Standard of Care
Inclusion Criteria:
- written informed consaent obtained
- hospitalized with COVID-19 disease
- Age >/= 18 years
- SARS CoV-2 NhO posit
- Sp=2 30 /min
- Any 2 of the 4: P-IL-6 > 2 x ULN / P-ferritin > 2 x ULN / P-FIDD >1.5 mg/l / P- CRP
>40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 <5.9
ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin
degradation products, D-dimer) <0.5 mg/l; P-CRP <10 mg/l)
Exclusion Criteria:
- Known severe allergic reactions to monoclonal antibodies
- Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or
obvious other bacterial, fungal or viral infection (besides COVID-19)
- In the opinion of the clinical team, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatments
- Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids
equivalent to methylprednison 15mg/day)
- Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by
laboratory test (U-hCG-O).
- Participating in other drug clinical trials
- Absolute neutrophil count < 1 x10E9/l
- Platelet count <50 x10E9/l
- ALAT >10x ULN
Turku University Hospital
Turku, Finland