Maskin 2021.

Study characteristics
Methods	Trial design: multicentre, open‐label, randomised controlled trial Type of publication: journal publication Setting: inpatient (ICU) Recruitment dates: 17 June 2020 and 27 March 2021 Country: Argentina Language: English Number of centres: 5 Trial registration number: NCT04395105 Date of trial registration: 16 May 2020
Participants	Age: Mean age (SD): 60.04 years (± 13.08) in the low‐dose group Mean age (SD): 63.57 years (± 13.59) in the high‐dose group Gender: 16 female (33%) in the low‐dose group 13 female (26%) in the high‐dose group Ethnicity: not stated Number of participants (recruited/allocated/evaluated): 100/49 in the high‐dose group and 51 in the low‐dose group/49 in the high‐dose group and 49 in the low‐dose group Severity of condition according to study definition: receiving mechanical ventilation Severity of condition according to WHO score: severe ≥ 7 Co‐morbidities: Charlson’s comorbidity index is used, otherwise not stated Inclusion criteria: aged 18 years old or more, who had ARDS according to the Berlin Definition criteria, who had confirmed SARS‐CoV‐2 infection by reverse transcription polymerase chain reaction and were receiving mechanical ventilation for less than 72 hours Exclusion criteria: pregnant or breastfeeding women, terminal disease, therapeutic limitation, severe immunosuppression, chronic treatment with glucocorticoids, participation in another randomised clinical trial, prior use of dexamethasone for COVID‐19 (> 5 days), or consent refusal Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): mechanical ventilation
Interventions	Details of intervention: dexamethasone + standard care Dose: 16 mg once daily for 5 days, followed by 8 mg administered once daily for additional 5 days Route of administration: intravenous Treatment details of control group (e.g. dose, route of administration): 6 mg of dexamethasone intravenously per day for 10 days + standard care Concomitant therapy: —
Outcomes	Primary study outcome: ventilator‐free days during the first 28 days (defined as the number of days alive and free from mechanical ventilation up to the 28th day from randomisation), co‐primary outcome: the time to complete and successful discontinuation of mechanical ventilation or death Review outcomes: inpatient setting Mortality: all‐cause mortality at day 14 or any longer observation period, in‐hospital all‐cause mortality: reported Improvement of clinical status during the longest observation period available: Ventilator‐free days (defined as days alive and free from mechanical ventilation): reported Participants discharged alive. Participants should be discharged without clinical deterioration or death: not reported Deterioration of clinical status during the longest observation period available: New need for invasive mechanical ventilation or death; that is, transition to WHO 7 to 9 if 6 or lower at baseline (see Figure 1): not reported Serious adverse events, defined as the number of participants with any event: not reported Adverse events (any grade), defined as the number of participants with any event: not reported Specific adverse events: hospital‐acquired infections: reported Fungal infections: not reported Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) during the longest period available: not reported New need for dialysis during the longest period available: not reported Viral clearance, assessed with reverse transcription polymerase chain reaction (RT‐PCR) test for SARS‐CoV‐2 at baseline, up to 3, 7, and 15 days: not reported Additional study outcomes: the daily value of glucose and insulin dose, muscle strength score, and the frequency of delirium within 28 days of randomisation
Identification
Notes	Date of publication: 29 November 2021 Sponsor/funding: —