Cargando…
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 compr...
Autores principales: | , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Associação de Medicina Intensiva Brasileira - AMIB
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595716/ https://www.ncbi.nlm.nih.gov/pubmed/33053024 http://dx.doi.org/10.5935/0103-507X.20200063 |
_version_ | 1783601939261423616 |
---|---|
author | Tomazini, Bruno Martins Maia, Israel Silva Bueno, Flavia Regina Silva, Maria Vitoria Aparecida Oliveira Baldassare, Franca Pellison Costa, Eduardo Leite Vieira Moura, Ricardo Antonio Bonifácio Honorato, Michele Ouriques Costa, André Nathan Cavalcanti, Alexandre Biasi Rosa, Regis Goulart Avezum, Álvaro Veiga, Viviane Cordeiro Lopes, Renato Delascio Damiani, Lucas Petri Machado, Flávia Ribeiro Berwanger, Otavio de Azevedo, Luciano César Pontes |
author_facet | Tomazini, Bruno Martins Maia, Israel Silva Bueno, Flavia Regina Silva, Maria Vitoria Aparecida Oliveira Baldassare, Franca Pellison Costa, Eduardo Leite Vieira Moura, Ricardo Antonio Bonifácio Honorato, Michele Ouriques Costa, André Nathan Cavalcanti, Alexandre Biasi Rosa, Regis Goulart Avezum, Álvaro Veiga, Viviane Cordeiro Lopes, Renato Delascio Damiani, Lucas Petri Machado, Flávia Ribeiro Berwanger, Otavio de Azevedo, Luciano César Pontes |
author_sort | Tomazini, Bruno Martins |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7595716 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Associação de Medicina Intensiva Brasileira - AMIB |
record_format | MEDLINE/PubMed |
spelling | pubmed-75957162020-11-03 COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial Tomazini, Bruno Martins Maia, Israel Silva Bueno, Flavia Regina Silva, Maria Vitoria Aparecida Oliveira Baldassare, Franca Pellison Costa, Eduardo Leite Vieira Moura, Ricardo Antonio Bonifácio Honorato, Michele Ouriques Costa, André Nathan Cavalcanti, Alexandre Biasi Rosa, Regis Goulart Avezum, Álvaro Veiga, Viviane Cordeiro Lopes, Renato Delascio Damiani, Lucas Petri Machado, Flávia Ribeiro Berwanger, Otavio de Azevedo, Luciano César Pontes Rev Bras Ter Intensiva Original Article 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. Associação de Medicina Intensiva Brasileira - AMIB 2020 /pmc/articles/PMC7595716/ /pubmed/33053024 http://dx.doi.org/10.5935/0103-507X.20200063 Text en http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Tomazini, Bruno Martins Maia, Israel Silva Bueno, Flavia Regina Silva, Maria Vitoria Aparecida Oliveira Baldassare, Franca Pellison Costa, Eduardo Leite Vieira Moura, Ricardo Antonio Bonifácio Honorato, Michele Ouriques Costa, André Nathan Cavalcanti, Alexandre Biasi Rosa, Regis Goulart Avezum, Álvaro Veiga, Viviane Cordeiro Lopes, Renato Delascio Damiani, Lucas Petri Machado, Flávia Ribeiro Berwanger, Otavio de Azevedo, Luciano César Pontes COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title | COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title_full | COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title_fullStr | COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title_full_unstemmed | COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title_short | COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial |
title_sort | covid-19-associated ards treated with dexamethasone (codex): study design and rationale for a randomized trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595716/ https://www.ncbi.nlm.nih.gov/pubmed/33053024 http://dx.doi.org/10.5935/0103-507X.20200063 |
work_keys_str_mv | AT tomazinibrunomartins covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT maiaisraelsilva covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT buenoflaviaregina covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT silvamariavitoriaaparecidaoliveira covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT baldassarefrancapellison covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT costaeduardoleitevieira covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT mouraricardoantoniobonifacio covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT honoratomicheleouriques covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT costaandrenathan covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT cavalcantialexandrebiasi covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT rosaregisgoulart covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT avezumalvaro covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT veigavivianecordeiro covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT lopesrenatodelascio covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT damianilucaspetri covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT machadoflaviaribeiro covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT berwangerotavio covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT deazevedolucianocesarpontes covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial AT covid19associatedardstreatedwithdexamethasonecodexstudydesignandrationaleforarandomizedtrial |