Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.Trial designREMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice.ParticipantsThe study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic.Inclusion criteriaSubjects will be eligible for the trial if they meet all of the following criteria:1. Adult ( ≥18 years of age) at time of enrolment;2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing);3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy;4. Moderate or severe ARDS according to Berlin criteria: • Moderate – PaO2/FiO2 100 –200 mmHg; • Severe – PaO2/FiO2< 100 mmHg;5. Admission to ICU in the last 24 hours.Exclusion criteriaSubjects will not be eligible for the trial if they meet any of ...
Source: Trials - Category: Research Source Type: clinical trials