NCT04438980.

Methods	Trial design: double‐blinded RCT Sample size: 72 Setting: inpatient Language: Spanish, English Number of centres: 2 Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria Age ≥ 18 years old Diagnosis of SARS‐CoV‐2 pneumonia confirmed by RT‐PCR on nasopharyngeal swab or sputum according to the recommendations of the Spanish Ministry of Health Length of symptoms consistent with COVID‐19 ≥ 7 days Hospital admission At least one of the following: CRP > 60 mg/L IL‐6 > 40 pg/mL Ferritin > 1000 μg/L. Acceptance of informed consent Exclusion criteria Allergy or contraindication to any of the drugs under study SpO2 < 90% (in air ambient) or PaO2 < 60 mmHg (in ambient air) or PaO2/FiO2 < 300 mmHg Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with another indication Decompensated diabetes mellitus Uncontrolled hypertension Psychotic or manic disorder Active cancer Pregnancy or lactation Clinical or biochemical suspicion (procalcitonin > 0.5 ng/mL) of active infection other than SARS‐CoV‐2 Out‐of‐hospital management patient Conservative or palliative management patient Participation in another clinical trial Any important and uncontrolled medical, psychological, psychiatric, geographic, or social problem that contraindicates the patient's participation in the trial or that does not allow adequate follow‐up and adherence to the protocol and evaluation of the study results.
Interventions	Details of intervention Dose: methylprednisolone 120 mg/d for 3 days Route of administration: IV Treatment details of control group (e.g. dose, route of administration): standard care and infusion bag of 100 mL of 0.9% saline Concomitant therapy: no information
Outcomes	Primary outcome Death Need for admission in an ICU Need for mechanical ventilation Decrease in SpO2 < 90% (in ambient air) or PaO2 < 60 mmHg (in ambient air) or PaO2/FiO2 < 300 mmHg, associated with radiological impairment (time frame: at 14 days after randomisation)
Notes	Recruitment status: completed Prospective completion date: February 2021 Date last update was posted: 22 July 2020 Sponsor/funding: Fundacion Miguel Servet