COVID-19: Salvage TOcilizumab as a Rescue Measure
- Conditions
- Covid19
- Interventions
- Drug: iv Tocillizumab (TCZ)
- Registration Number
- NCT04577534
- Lead Sponsor
- Jarmo Oksi
- Brief Summary
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tocilizumab (TCZ) iv Tocillizumab (TCZ) Participants will receive one infusion of iv TCZ (according to weight of patient)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method CCI 28 days during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
SAPS II 28 days during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (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
Incidence of ICU stay 28 days ICU admission day
Time to clinical failure 28 days time to death, mechanical ventilation, or ICU admission (whichever occurs first)
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.Organ failure free days to day 28 28 days days without organ failure
Duration of ICU stay 28 days days on ICU
Time to clinical improvement 28 days defined as a National Early Warning Score 2 (NEWS2) of\>/=2 maintained for 24 hours
Time to decline of at least 2 categories 28 days relative on a 7-category ordinalscale of clinical status
Number of ventilator-free days to day 28 28 days days not in ventilator
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)
Duration of supplemental oxygen 28 days days on suppl oxygen
Trial Locations
- Locations (1)
Turku University Hospital
🇫🇮Turku, Finland