| Id |
Subject |
Object |
Predicate |
Lexical cue |
| T1 |
0-153 |
Sentence |
denotes |
Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS). |
| T2 |
154-317 |
Sentence |
denotes |
Justificativa e delineamento do estudo “Tocilizumabe em pacientes com COVID-19 moderado a grave: estudo aberto, multicêntrico, randomizado, controlado” (TOCIBRAS). |
| T3 |
318-331 |
Sentence |
denotes |
INTRODUCTION: |
| T4 |
332-431 |
Sentence |
denotes |
Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. |
| T5 |
432-570 |
Sentence |
denotes |
Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. |
| T6 |
571-745 |
Sentence |
denotes |
We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19. |
| T7 |
746-767 |
Sentence |
denotes |
METHODS AND ANALYSIS: |
| T8 |
768-967 |
Sentence |
denotes |
This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. |
| T9 |
968-1162 |
Sentence |
denotes |
Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. |
| T10 |
1163-1311 |
Sentence |
denotes |
The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. |
| T11 |
1312-1470 |
Sentence |
denotes |
The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex). |
| T12 |
1471-1496 |
Sentence |
denotes |
ETHICS AND DISSEMINATION: |
| T13 |
1497-1660 |
Sentence |
denotes |
The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. |
| T14 |
1661-1793 |
Sentence |
denotes |
Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. |
| T15 |
1794-1871 |
Sentence |
denotes |
The data derived from this trial will be published regardless of the results. |
| T16 |
1872-2023 |
Sentence |
denotes |
If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes. |
| T1 |
0-153 |
Sentence |
denotes |
Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS). |
| T2 |
154-317 |
Sentence |
denotes |
Justificativa e delineamento do estudo “Tocilizumabe em pacientes com COVID-19 moderado a grave: estudo aberto, multicêntrico, randomizado, controlado” (TOCIBRAS). |
| T3 |
318-331 |
Sentence |
denotes |
INTRODUCTION: |
| T4 |
332-431 |
Sentence |
denotes |
Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. |
| T5 |
432-570 |
Sentence |
denotes |
Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. |
| T6 |
571-745 |
Sentence |
denotes |
We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19. |
| T7 |
746-767 |
Sentence |
denotes |
METHODS AND ANALYSIS: |
| T8 |
768-967 |
Sentence |
denotes |
This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. |
| T9 |
968-1162 |
Sentence |
denotes |
Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. |
| T10 |
1163-1311 |
Sentence |
denotes |
The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. |
| T11 |
1312-1470 |
Sentence |
denotes |
The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex). |
| T12 |
1471-1496 |
Sentence |
denotes |
ETHICS AND DISSEMINATION: |
| T13 |
1497-1660 |
Sentence |
denotes |
The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. |
| T14 |
1661-1793 |
Sentence |
denotes |
Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. |
| T15 |
1794-1871 |
Sentence |
denotes |
The data derived from this trial will be published regardless of the results. |
| T16 |
1872-2023 |
Sentence |
denotes |
If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes. |