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.
【저자키워드】 Respiratory distress syndrome, adult, Adrenal cortex hormones, Síndrome do desconforto respiratório do adulto, Corticosteroides, Cuidados críticos, Dexametasona, 【초록키워드】 Corticosteroid, COVID-19, Dexamethasone, coronavirus disease, SARS-CoV-2, Respiratory distress syndrome, Coronavirus disease 2019, coronavirus, Corticosteroids, clinical trial, pandemic, Trial, Open-label, randomization, intensive care, acute respiratory distress syndrome, mechanical ventilation, Pneumonia, SARS-COV-2 infection, Infection, outcome, hospitalized patients, severe acute respiratory syndrome Coronavirus, clinical status, Spread, Viral pneumonia, Randomized, Viral, Patient, Effectiveness, Controlled trial, Control, Ventilator-free days, multicenter, respiratory, assessment, group, mortality rates, moderate, score, acute respiratory distress, Ordinal Scale, Invasive mechanical ventilation, administration, Pragmatic, intravenous, followed by, respiratory distress, 48 hours, once daily, unit discharge, Non-COVID-19, acute respiratory syndrome, Primary outcome, control group, intervention group, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, Eligible patients, Secondary outcomes, failure, standard treatment, Adult patients, syndrome, 350 patients, 6-level ordinal scale, all-cause mortality rates, Berlin criteria, coronavirus disease 2019 - COVID-19, early-onset, mechanical ventilation duration, non-COVID-19 acute respiratory distress syndrome, respiratory compromise, objective, secondary, Randomly, all-cause mortality rate, defined, develop, evaluate, caused, evaluated, less, occur, hospitalized patient, stratified, receive, 350 patient, 48 hour, days alive, dexamethasone 10mg IV, dexamethasone 20mg intravenous, patients with moderate, ventilator-free day, 【제목키워드】 Dexamethasone, randomized trial, Study design, COVID-19-associated ARDS, treated,