Jamaati 2021.

Study characteristics
Methods	Trial design: RCT Type of publication: journal publication Setting: inpatient Recruitment dates: March 2020 Country: Iran Language: English Number of centres: 1 Trial registration number: IRCT20151227025726N17 Date of trial registration: 31 May 2020
Participants	Age: median age Intervention group survivor: 54 years (IQR 37 to 63) Intervention group non‐survivor: 63 years (IQR 55.5 to 72.5) Control group survivor: 61.5 years (IQR 54 to 62) Control group non‐survivor: 67 years (IQR 48 to 73) Gender (male, n(%)): Intervention group: 18 (72) Control group: 18 (72) Proportion of confirmed infections: PCR positivity inclusion criterion Ethnicity: not reported Number of participants (recruited/allocated/evaluated): Recruited: no information Allocated: 25 intervention group and 25 control group Evaluated: 25 intervention group and 25 control group Severity of condition according to study definition: PaO2/FiO2 between 100 and 300 mmHg Severity of condition according to WHO score: most likely 5, no invasive ventilation at randomisation Co‐morbidities: diabetes, hypertension, cardiovascular disease Inclusion criteria Age > 18 years SARS‐CoV‐2 infection confirmed by RT‐PCR PaO2/FiO2 between 100 and 300 mmHg Bilateral lung infiltration Provision of written informed consent by the patient Exclusion criteria Patients with chronic kidney diseases Patients with chronic liver diseases Patients with hyperglycaemia Pregnant or breastfeeding women Previous treatments: not reported
Interventions	Treatment details of intervention group (e.g. dose, route of administration, number of doses) Type of corticosteroid: dexamethasone Dose: 20 mg/day from day 1 to 5 and then at 10 mg/day from day 6 to 10 Route of administration: IV Treatment details of control group (e.g. dose, route of administration, number of doses) Standard care Concomitant therapy (e.g. description of standard care): oxygen support, fluid support, lopinavir/ritonavir (200/50 mg, 2 tablets twice a day) Duration of follow‐up: 28 days Treatment cross‐overs: no Compliance with assigned treatment: yes
Outcomes	Primary study outcome: need for IMV, death rate 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: 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: not reported Additional study outcomes: duration of clinical improvement, radiological changes in the CT scan
Identification
Notes	Date of publication: 16 February 2021 Sponsor/funding: Shahid Beheshti University of Medical Sciences