Jeronimo 2020.

Study characteristics
Methods	Trial design: double‐blind RCT Type of publication: journal publication Setting: inpatient Recruitment dates: 18 April to 16 June 2020 Country: Brazil Language: English Number of centres: 1 Trial registration number: NCT04343729 Date of trial registration: 13 April 2020
Participants	Age: mean age 54 years (SD 15) in the intervention group 57 years (SD 15) in the control group Gender 68 female (35.1%) in the intervention group 71 female (35.7%) in the control group Proportion of PCR test results Positive: 83.4% intervention arm, 79.3% control arm Negative: not reported Unclear: not reported Ethnicity: white, black, admixed, Asian, Amerindian Number of participants (recruited/allocated/evaluated) Recruited: 425 Allocated: 209 intervention group and 207 in the control group Evaluated: 195 intervention group and 202 control group Severity of condition according to study definition IMV at baseline: 66 (34%) intervention group; 67 (33.7%) control group Non‐invasive oxygen therapy at baseline: 98 (50.5%) intervention group; (45.2%) 90 control group Severity of condition according to WHO score: moderate to severe: 5 to 9 Co‐morbidities: diabetes, hypertension, alcohol use disorder, heart disease, asthma, rheumatic disease, liver disease, previous tuberculosis, COPD Inclusion criteria Clinical and/or radiological suspicion of COVID‐19 (history of fever and any respiratory symptom; eg, cough or dyspnoea and/or ground glass opacity or pulmonary consolidation on CT scan) Aged ≥ 18 years Either had SpO2 ≤ 94% with room air, required supplementary oxygen, or required IMV Exclusion criteria History of hypersensitivity to methylprednisolone Living with HIV or AIDS Had a history of chronic use of corticosteroids or immunosuppressive agents Were pregnant or breastfeeding Had decompensated cirrhosis or chronic renal failure Previous treatments: not reported
Interventions	Treatment details of intervention group (e.g. dose, route of administration, number of doses): Type of corticosteroid: methylprednisolone Dose: 0.5 mg/kg twice daily for 5 days Route of administration: IV Treatment details of control group (e.g. dose, route of administration, number of doses): placebo Concomitant therapy (e.g. description of standard care): all patients meeting ARDS criteria used pre‐emptive IV ceftriaxone (1 g twice a day for 7 days) plus azithromycin (500 mg once a day for 5 days) or clarithromycin (500 mg twice a day for 7 days), starting on day 1 Duration of follow‐up: 28 days Treatment cross‐overs: no Compliance with assigned treatment: yes
Outcomes	Primary study outcome: 28‐day mortality 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): not 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: not 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: 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: reported Additional study outcomes: none
Identification
Notes	Date of publication: 12 August 2020 Sponsor/funding: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado