EUCTR2020‐006054‐43‐IT.

Study name	Randomised controlled trial of methylprednisolone versus dexamethasone in COVID‐19 pneumonia ‐ methylprednisolone vs dexamethasone in COVID‐19
Methods	Trial design: open‐label, randomised controlled trial Sample size: 680 Setting: inpatient Language: English Number of centres: not stated Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria: Able to understand and sign the informed consent form SARS‐CoV‐2 positive on at least one upper respiratory swab or bronchoalveolar lavage PaO2 ≤ 60 mmHg or SpO2 ≤ 90% or on HFNC, CPAP or NPPV at randomisation Age ≥ 18 years old at randomisation Exclusion criteria: On invasive mechanical ventilation (either intubated or tracheostomised) Heart failure as the main cause of acute respiratory failure On long‐term oxygen or home mechanical ventilation Decompensated liver cirrhosis Immunosuppression (i.e. cancer on treatment, post‐organ transplantation, HIV‐positive, on immunosuppressant therapy) On chronic steroid therapy or other immunomodulant therapy (e.g. azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma) Chronic renal failure with dialysis dependence Progressive neuromuscular disorders Cognitively impaired, dementia or decompensated psychiatric disorder Quadriplegia/hemiplegia or quadriparesis/hemiparesis Do‐not‐resuscitate order Participating in other clinical trial including experimental compound with proved or expected activity against SARS‐CoV‐2 infection Any other condition that in the opinion of the investigator may significantly impact with patient’s capability to comply with protocol intervention Refuse to participate in the study or absence of signed informed consent form
Interventions	Details of intervention: methylprednisolone Dose: 1000 mg Route of administration: IV Treatment details of control group (e.g. dose, route of administration): dexamethasone, 8 mg, IV Concomitant therapy: not stated
Outcomes	Primary study outcome: survival proportion at 28 days in both arms
Starting date	3 March 2021
Contact information	Università degli Studi di Trieste, Strada di Fiume, 447 Trieste 34129, Italy Email: mconfalonieri@units.it
Notes	Recruitment status: ongoing Prospective completion date: not stated Date last update was posted: 26 July 2021 Sponsor/funding: Università degli Studi di Trieste