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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002039-31 | EudraCT Number | ||
| T124/2020 | Other Identifier | Turku University Hospital | |
| KLnro 36/2020 | Other Identifier | Fimea | |
| dnro 68/06.00.01/2020 | Other Identifier | TUKIJA / VALVIRA |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab (TCZ) | Experimental | Participants will receive one infusion of iv TCZ (according to weight of patient) |
|
| standard of care (no TCZ) | No Intervention | Participants will receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iv Tocillizumab (TCZ) | Drug | Participants are randomized (2:1) to receive TCZ or Standard of Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement | defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours | 28 days |
| Time to decline of at least 2 categories | relative on a 7-category ordinalscale of clinical status |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20521 | Finland |
plan to investigate if it is possible by law
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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. | 28 days |
| Number of ventilator-free days to day 28 | days not in ventilator | 28 days |
| Organ failure free days to day 28 | days without organ failure | 28 days |
| Incidence of ICU stay | ICU admission day | 28 days |
| Duration of ICU stay | days on ICU | 28 days |
| Time to clinical failure | time to death, mechanical ventilation, or ICU admission (whichever occurs first) | 28 days |
| SAPS II | during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst) | 28 days |
| CCI | during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst) | 28 days |
| APACHE II | during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst) | 28 days |
| SOFA 6 | during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst) | 28 days |
| Mortality rate | during and end of period of 28 days | 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 \ | 28 days |
| Duration of supplemental oxygen | days on suppl oxygen | 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |