A Phase 3 interventional study of iv Tocillizumab (TCZ) in Covid19, sponsored by Jarmo Oksi. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Jarmo Oksi · Phase 3, Interventional, and Treatment
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 88 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Jarmo Oksi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive one infusion of iv TCZ (according to weight of patient)
Drug: iv Tocillizumab (TCZ)
Participants will receive standard of care
Participants are randomized (2:1) to receive TCZ or Standard of Care
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
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
Plan to share: Undecided — plan to investigate if it is possible by law
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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