Song 2021.

Methods	Trial design: open‐label, randomised Type of publication: journal publication Setting: inpatient Recruitment dates: 8 May 2020 to 31 March 2021 Country: South Korea Language: English Number of centres: 6 Trial registration number: NCT04330586 Date of trial registration: 31 March 2020
Participants	Age: mean: 44.9 (SD 17.9) years in the intervention group 49.0 (SD 16.8) years in the control group Sex: 11 (31.4%) male in the intervention group 9 (34.6%) male in the control group Proportion of confirmed infections: 100% (confirmed by qRT‐PCR) Ethnicity: not stated Number of participants: recruited: 61 allocated: 35 the intervention group and 26 in the control group evaluated: 35 in intervention group and 26 in the control group Severity of condition according to study definition: low NEWS Comorbidities: diabetes, hypertension, cerebrovascular diseases Inclusion criteria: low NEWS ranging from 0 to 4 (NEWS is a scoring system based on routine physiological parameters (respiratory rate, oxygen saturation, supplemental oxygen, body temperature, systolic blood pressure, heart rate, and level of consciousness)) Exclusion criteria: oxygen saturation < 95% breathing room air pregnancy or breastfeeding renal impairment (estimated creatinine clearance < 30 mL/minute) hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels > 5 times the upper limit of normal) immunocompromising conditions severe uncontrolled comorbidities chronic airway diseases (asthma and chronic obstructive lung disease) contraindications for use of ciclesonide inhaler Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): no
Interventions	Intervention group: inhaled ciclesonide 320 µg twice daily for 14 days Control group: standard care Concomitant therapy: standard care (intravenous fluid, supplementary oxygen, antibiotics) Duration of follow‐up: 14 days Treatment cross‐overs: no Compliance with assigned treatment: yes
Outcomes	Primary outcome: SARS‐CoV‐2 eradication rate based on qRT‐PCR on day 14 Secondary outcomes: SARS‐CoV‐2 eradication rate based on at days 7 and 10 from study enrolment; rate of clinical improvement (resolution of all systemic and respiratory symptoms) at days 7, 10, and 14 from study enrolment; rate of clinical failure within 28 days; safety/tolerability of ciclesonide
Notes	Date of publication: 12 August 2021 Sponsor/funding: National Research Foundation of Korea (NRF) grant [2020M3A9I2081699] and Korea University Guro Hospital grant (I2000171)

ARDS: acute respiratory distress syndrome; BIPAP: bilevel positive airway pressure; COVID‐19: coronavirus disease 2019; CPAP: continuous positive airway pressure; CT: computer tomography; ICU: intensive care unit; IL: interleukin; NEWS: National Early Warning Score; OMS: ordinal measurement scale; PCR: polymerase chain reaction; PiO₂/FiO₂: inspired oxygen tension/fraction of inspired oxygen; PaO₂/FiO₂: arterial oxygen partial pressure/fraction of inspired oxygen; PROMIS: Patient‐Reported Outcomes Measurement Information System; qRT‐PCR: quantitative reverse transcription polymerase chain reaction; RCT: randomised controlled trial; RT‐PCR: real‐time polymerase chain reaction.