Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Participants are randomized (2:1) to receive TCZ or Standard of Care
Turku University Hospital
Turku, Finland
Clinical status at 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
Time frame: day 28
Time to clinical improvement
defined as a National Early Warning Score 2 (NEWS2) of\>/=2 maintained for 24 hours
Time frame: 28 days
Time to decline of at least 2 categories
relative on a 7-category ordinalscale of clinical status
Time frame: 28 days
Incidence of mechanical and/or non-invasive ventilation
(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.
Time frame: 28 days
Number of ventilator-free days to day 28
days not in ventilator
Time frame: 28 days
Organ failure free days to day 28
days without organ failure
Time frame: 28 days
Incidence of ICU stay
ICU admission day
Time frame: 28 days
Duration of ICU stay
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days on ICU
Time frame: 28 days
Time to clinical failure
time to death, mechanical ventilation, or ICU admission (whichever occurs first)
Time frame: 28 days
SAPS II
during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)
Time frame: 28 days
CCI
during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
Time frame: 28 days
APACHE II
during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)
Time frame: 28 days
SOFA 6
during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)
Time frame: 28 days
Mortality rate
during and end of period of 28 days
Time frame: 28 days
Time to hospital discharge or "ready for discharge"
as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or \</=2 l supplemental oxygen
Time frame: 28 days
Duration of supplemental oxygen
days on suppl oxygen
Time frame: 28 days