NCT04325061.

Methods	Trial design: open‐label RCT Sample size: 19 Setting: inpatient Language: English Number of centres: multicentre Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age ≥ 18 years Positive RT‐PCR assay for COVID‐19 in a respiratory tract sample Intubated and mechanically ventilated Acute onset of ARDS, as defined by Berlin criteria as moderate‐to‐severe ARDS, which includes: having pneumonia or worsening respiratory symptoms; bilateral pulmonary infiltrates on chest imaging (X‐ray or CT scan) absence of left atrial hypertension, pulmonary capillary wedge pressure < 18 mmHg, or no clinical signs of left heart failure; hypoxaemia, as defined by a PaO2/FiO2 ratio of ≤ 200 mmHg on PEEP of ≥ 5 cm H2O, regardless of FiO2. Exclusion criteria Routine treatment with corticosteroids during the previous week irrespective of dose Corticosteroid use within the previous 24 h of > 20 mg of dexamethasone or equivalent Patients with a known contraindication to corticosteroids Decision by a physician that involvement in the study is not in the patient's best interest Pregnancy and breast‐feeding Participation in another therapeutic trial
Interventions	Details of intervention Dose: dexamethasone (20 mg/daily/from day 1 of randomisation for 5 days, followed by 10 mg/daily from day 6 to 10 of randomisation Route of administration: IV Treatment details of control group (e.g. dose, route of administration): patients will be treated with standard intensive care Concomitant therapy: no information
Outcomes	Primary study outcome: all‐cause mortality at 60 days after enrolment
Notes	Recruitment status: terminated (lack of enrolment) Prospective completion date: June 2020 Date last update was posted: February 2021 Sponsor/funding: Dr. Negrin University Hospital