Turku University Hospital
Turku, 20521, Finland
NCT Number: NCT04577534
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Turku, 20521, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants are randomized (2:1) to receive TCZ or Standard of Care
Time frame: 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: 28 days
defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours
Time frame: 28 days
relative on a 7-category ordinalscale of clinical status
Time frame: 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.
Time frame: 28 days
days not in ventilator
Time frame: 28 days
days without organ failure
Time frame: 28 days
ICU admission day
Time frame: 28 days
days on ICU
Time frame: 28 days
time to death, mechanical ventilation, or ICU admission (whichever occurs first)
Time frame: 28 days
during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)
Time frame: 28 days
during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
Time frame: 28 days
during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)
Time frame: 28 days
during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)
Time frame: 28 days
during and end of period of 28 days
Time frame: 28 days
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
days on suppl oxygen
Jarmo Oksi
Other Gov
COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Acronym: COVIDSTORM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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