COVID-19-associated ARDS treated with DEXamethasone (CoDEX) : study design and rationale for a randomized trial
OBJECTIVE: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19.
METHODS: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.
| 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: 21. Juli, Seite 354-362 |
| Sprache: |
Portugiesisch |
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| Weiterer Titel: |
Síndrome do desconforto respiratório agudo associada à COVID-19 tratada com DEXametasona (CoDEX): delineamento e justificativa de um estudo randomizado |
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| Beteiligte Personen: |
Tomazini, Bruno Martins [VerfasserIn] |
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| Links: |
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| Themen: |
7S5I7G3JQL |
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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.20200063 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a COVID-19-associated ARDS treated with DEXamethasone (CoDEX) |b study design and rationale for a randomized trial |
| 246 | 3 | 3 | |a Síndrome do desconforto respiratório agudo associada à COVID-19 tratada com DEXametasona (CoDEX): delineamento e justificativa de um estudo randomizado |
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| 500 | |a Date Revised 20.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVE: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19 | ||
| 520 | |a METHODS: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 650 | 7 | |a Glucocorticoids |2 NLM | |
| 700 | 1 | |a Maia, Israel Silva |e verfasserin |4 aut | |
| 700 | 1 | |a Bueno, Flavia Regina |e verfasserin |4 aut | |
| 700 | 1 | |a Silva, Maria Vitoria Aparecida Oliveira |e verfasserin |4 aut | |
| 700 | 1 | |a Baldassare, Franca Pellison |e verfasserin |4 aut | |
| 700 | 1 | |a Costa, Eduardo Leite Vieira |e verfasserin |4 aut | |
| 700 | 1 | |a Moura, Ricardo Antonio Bonifácio |e verfasserin |4 aut | |
| 700 | 1 | |a Honorato, Michele Ouriques |e verfasserin |4 aut | |
| 700 | 1 | |a Costa, André Nathan |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 Avezum, Álvaro |e verfasserin |4 aut | |
| 700 | 1 | |a Veiga, Viviane Cordeiro |e verfasserin |4 aut | |
| 700 | 1 | |a Lopes, Renato Delascio |e verfasserin |4 aut | |
| 700 | 1 | |a Damiani, Lucas Petri |e verfasserin |4 aut | |
| 700 | 1 | |a Machado, Flávia Ribeiro |e verfasserin |4 aut | |
| 700 | 1 | |a Berwanger, Otavio |e verfasserin |4 aut | |
| 700 | 1 | |a Azevedo, Luciano César Pontes de |e verfasserin |4 aut | |
| 700 | 0 | |a em nome dos investigadores da COALIZÃO COVID-19 BRASIL III |e verfasserin |4 aut | |
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