• Tomazini Bruno Martins BM http://orcid.org/0000-0001-6763-6132 Hospital Sírio-Libanês - São Paulo (SP), Brasil. , Israel Silva Maia, Flavia Regina Bueno, Maria Vitoria Aparecida Oliveira Silva, Franca Pellison Baldassare, Costa Eduardo Leite Vieira ELV http://orcid.org/0000-0002-6941-3626 Hospital Sírio-Libanês - São Paulo (SP), Brasil., Ricardo Antonio Bonifácio Moura, Michele Ouriques Honorato, André Nathan Costa, Alexandre Biasi Cavalcanti, Regis Goulart Rosa, Álvaro Avezum, Viviane Cordeiro Veiga, Renato Delascio Lopes, Lucas Petri Damiani, Flávia Ribeiro Machado, Otavio Berwanger, Azevedo Luciano César Pontes de LCP http://orcid.org/0000-0001-6759-3910 Hospital Sírio-Libanês - São Paulo (SP), Brasil. , and em nome dos investigadores da COALIZÃO COVID-19 BRASIL III.
• Hospital Sírio-Libanês - São Paulo (SP), Brasil.
• Rev Bras Ter Intensiva. 2020 Jul 1; 32 (3): 354-362.

ObjectiveThe 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.MethodsThis 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.

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