Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19 : an open-label multicentre randomized controlled" trial (TOCIBRAS)
INTRODUCTION: Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. 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.
METHODS AND ANALYSIS: 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. 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. 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. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
ETHICS AND DISSEMINATION: The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:32 |
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| Enthalten in: |
Revista Brasileira de terapia intensiva - 32(2020), 3 vom: 15. Juli, Seite 337-347 |
| Sprache: |
Portugiesisch |
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| Weiterer Titel: |
Justificativa e delineamento do estudo “Tocilizumabe em pacientes com COVID-19 moderado a grave: estudo aberto, multicêntrico, randomizado, controlado” (TOCIBRAS) |
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| Beteiligte Personen: |
Farias, Danielle Leão Cordeiro de [VerfasserIn] |
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| Links: |
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| Themen: |
Anti-Inflammatory Agents |
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| Anmerkungen: |
Date Completed 26.10.2020 Date Revised 20.03.2024 published: Print Citation Status MEDLINE |
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| doi: |
10.5935/0103-507X.20200060 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19 |b an open-label multicentre randomized controlled" trial (TOCIBRAS) |
| 246 | 3 | 3 | |a Justificativa e delineamento do estudo “Tocilizumabe em pacientes com COVID-19 moderado a grave: estudo aberto, multicêntrico, randomizado, controlado” (TOCIBRAS) |
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| 500 | |a Date Completed 26.10.2020 | ||
| 500 | |a Date Revised 20.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. 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 | ||
| 520 | |a METHODS AND ANALYSIS: 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. 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. 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. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex) | ||
| 520 | |a ETHICS AND DISSEMINATION: The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Anti-Inflammatory Agents |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a Interleukin-6 |2 NLM | |
| 650 | 7 | |a tocilizumab |2 NLM | |
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| 700 | 1 | |a Prats, João |e verfasserin |4 aut | |
| 700 | 1 | |a Cavalcanti, Alexandre Biasi |e verfasserin |4 aut | |
| 700 | 1 | |a Rosa, Regis Goulart |e verfasserin |4 aut | |
| 700 | 1 | |a Machado, Flávia Ribeiro |e verfasserin |4 aut | |
| 700 | 1 | |a Berwanger, Otávio |e verfasserin |4 aut | |
| 700 | 1 | |a Azevedo, Luciano César Pontes de |e verfasserin |4 aut | |
| 700 | 1 | |a Lopes, Renato Delascio |e verfasserin |4 aut | |
| 700 | 1 | |a Avezum, Álvaro |e verfasserin |4 aut | |
| 700 | 1 | |a Kawano-Dourado, Leticia |e verfasserin |4 aut | |
| 700 | 1 | |a Damiani, Lucas Petri |e verfasserin |4 aut | |
| 700 | 1 | |a Rojas, Salomón Soriano Ordinola |e verfasserin |4 aut | |
| 700 | 1 | |a Oliveira, Cleyton Zanardo de |e verfasserin |4 aut | |
| 700 | 1 | |a Andrade, Luis Eduardo Coelho |e verfasserin |4 aut | |
| 700 | 1 | |a Sandes, Alex Freire |e verfasserin |4 aut | |
| 700 | 1 | |a Pintão, Maria Carolina |e verfasserin |4 aut | |
| 700 | 1 | |a Castro Júnior, Claudio Galvão de |e verfasserin |4 aut | |
| 700 | 1 | |a Scheinberg, Phillip |e verfasserin |4 aut | |
| 700 | 1 | |a Veiga, Viviane Cordeiro |e verfasserin |4 aut | |
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