Tang 2021.

Study characteristics
Methods	Trial design: prospective, multicentre, single‐blind RCT Type of publication: journal publication Setting: inpatient Recruitment dates: 19 February 2020 to 31 March 2020 Country: China Language: English Number of centres: 7 Trial registration number: NCT04273321 Date of trial registration: 15 February 2020
Participants	Age: median age 57 years (IQR 49 to 67) in the intervention group 55 years (IQR 38 to 65) in the control group Gender 21 male (48.8%) in the intervention group 20 male (46.5%) in the control group Proportion of confirmed infections: PCR positivity inclusion criterion Ethnicity: not reported Number of participants (recruited/allocated/evaluated): 213 Allocated: 43 in the intervention group and 43 in the control group Evaluated: 43 in the intervention group and 43 in the control group Severity of condition according to study definition: COVID‐19 pneumonia (confirmed by chest‐CT) Admitted to the general wards Severity of condition according to WHO score: moderate to severe 4 to 6 Co‐morbidities: COPD, asthma, hypertension, coronary heart disease, diabetes, chronic renal failure Inclusion criteria Age > 18 years old Confirmed SARS‐CoV‐2 infection Admitted in the general wards Able to sign informed consent Exclusion criteria Severe immunosuppression (HIV infection, long‐term use of immunosuppressive agents) Pregnant or lactation period women Glucocorticoids are needed for other diseases Unwilling or unable to participate or complete the study Participating in other study Previous treatments: not reported
Interventions	Treatment details of intervention group (e.g. dose, route of administration, number of doses) Type of corticosteroid: methylprednisolone Dose: 1 mg/kg/day in 100 mL 0.9% NaCl for 7 days Route of administration: intravenous Treatment details of control group (e.g. dose, route of administration, number of doses) 100 mL 0.9% NaCl IV and standard care Concomitant therapy (e.g. description of standard care): standard therapy of COVID‐19: according to the Chinese Diagnosis and Treatment Plan for COVID‐19 (trial version 6); antivirals: 67 (77.9%) of patients, antibiotics: 61 (70.9%) of patients Duration of follow‐up: at least 14 days after randomisation or until hospital discharge Treatment cross‐overs: none documented Compliance with assigned treatment: yes
Outcomes	Primary study outcome: clinical deterioration 14 days after randomisation 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: 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: reported Additional study outcomes: clinical deterioration 14 days after randomisation (defined as deterioration of clinical signs and symptoms, new pulmonary or extrapulmonary lesions, progress in chest CT, ICU admission or death); clinical cure 14 days after randomisation (defined as improvement of clinical signs and symptoms of COVID‐19 and no need of additional therapy); time from randomisation to clinical cure, median (IQR), days; ICU admission
Identification
Notes	Date of publication: 22 January 2021 Sponsor/funding: Beijing Chao Yang Hospital