Covid19
Conditions
Keywords
COVID-19, new coronavirus disease, tocilizumab
Brief summary
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
Interventions
DRUGiv Tocillizumab (TCZ)
Participants are randomized (2:1) to receive TCZ or Standard of Care
Sponsors
Jarmo Oksi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* written informed consaent obtained * hospitalized with COVID-19 disease * Age \>/= 18 years * SARS CoV-2 NhO posit * Sp=2 \</93% on ambient air or respiratory rate \>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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical status at day 28 | day 28 | (assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal 1 not in hospital, back to normal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to decline of at least 2 categories | 28 days | relative on a 7-category ordinalscale of clinical status |
| Incidence of mechanical and/or non-invasive ventilation | 28 days | (mode and duration of respiratory support) Hospital day when respiratory support needed with non-invasive ventilation - and duration. Hospital day when respiratory support needed by invasive mechanical ventilation -and duration. |
| Number of ventilator-free days to day 28 | 28 days | days not in ventilator |
| Organ failure free days to day 28 | 28 days | days without organ failure |
| Incidence of ICU stay | 28 days | ICU admission day |
| Duration of ICU stay | 28 days | days on ICU |
| Time to clinical failure | 28 days | time to death, mechanical ventilation, or ICU admission (whichever occurs first) |
| Time to clinical improvement | 28 days | defined as a National Early Warning Score 2 (NEWS2) of\>/=2 maintained for 24 hours |
| CCI | 28 days | during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst) |
| APACHE II | 28 days | during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst) |
| SOFA 6 | 28 days | during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst) |
| Mortality rate | 28 days | during and end of period of 28 days |
| Time to hospital discharge or ready for discharge | 28 days | as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or \</=2 l supplemental oxygen |
| Duration of supplemental oxygen | 28 days | days on suppl oxygen |
| SAPS II | 28 days | during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst) |
Countries
Finland
Outcome results
None listed