Yu 2021.

Study characteristics
Methods	Trial design: randomised platform trial Type of publication: journal publication Setting: outpatient Recruitment dates: 27 November 2020 to 31 March 2021 Country: UK Language: English Number of centres: not reported Trial registration number: ISRCTN86534580 Date of trial registration: 25 March 2021
Participants	Age: mean primary analysis population: 64.7 (SD 7.3) years in the intervention group 63.8 (SD 7.8) years in the control group concurrent randomisation population: 64.7 (SD 7.3) years in the intervention group 64.5 (SD 7.7) years in the control group Sex: primary analysis population: 404 (48%) male and 429 (52%) female in the intervention group 540 (48%) male and 586 (52%) female in the control group concurrent randomisation population: 404 (48%) male and 429 (51%) female in the intervention group 431 (49%) male and 455 (51%) female in the control group Proportion of confirmed infections: positive: 80% in the intervention group and 57.5% in the control group negative: 13% in the intervention group and 28.4% in the control group no result: 1% in the intervention group and 0.5% in the control group Missing: 7% in the intervention group and 13.6% in the control group Ethnicity: primary analysis population: white: 767 (92%) in the intervention group and 1038 (92%) in the control group mixed: 9 (1%) in the intervention group and 5 (< 1%) in the control group South Asian: 43 (5%) in the intervention group and 64 (6%) in the control group black: 6 (1%) in the intervention group and 4 (< 1%) in the control group other: 8 (1%) in the intervention group and 14 (1%) in the control group missing: 0 in the intervention group and 1 (< 1%) in the control group concurrent randomisation population: white: 767 (92%) in the intervention group and 820 (93%) in the control group mixed: 9 (1%) in the intervention group and 4 (< 1%) in the control group South Asian: 43 (5%) in the intervention group and 48 (5%) in the control group black: 6 (1%) in the intervention group and 3 (< 1%) in the control group other: 8 (1%) in the intervention group and 11 (1%) in the control group missing: 0 in the intervention group and 0 in the control group Number of participants: recruited: 4720 allocated: 1073 in the intervention group and 1988 in the control group evaluated: 787 in the intervention group and 838 in the control group (concurrent randomisation SARS‐CoV‐2‐positive population) Severity of condition according to study definition: ongoing symptoms of confirmed or suspected COVID‐19 (high temperature or new, continuous cough or change in sense of smell/taste, or a combination of these) within 14 days Comorbidities: asthma, chronic obstructive pulmonary disease, lung disease, diabetes mellitus, heart problems, liver disease, stroke or neurological problem, hypertension requiring medication Inclusion criteria: aged ≥ 65 years, or ≥ 50 years with comorbidities (heart disease, hypertension, asthma or lung disease, diabetes, hepatic impairment, stroke or neurological problems, weakened immune system, self‐reported obesity) had ongoing symptoms from polymerase chain reaction (PCR) confirmed or suspected COVID‐19 which started within the past 14 days Exclusion criteria: already taking inhaled or systemic corticosteroids unable to use an inhaler contraindication to inhaled budesonide Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): no
Interventions	Intervention group: inhaled budesonide 800 µg twice daily for 14 days + standard care Control group: standard care (antipyretics, antibiotics) Concomitant therapy: no
Outcomes	Primary outcomes: time to self‐reported recovery, defined as the first instance that a participant reported feeling recovered from possible COVID‐19; hospitalisation or death or both (both within 28 days) Secondary outcomes: rating of how well participants felt (scale 1–10); time to sustained recovery (date participant first reported feeling recovered and subsequently remained well until 28 days); early sustained recovery (reported feeling recovered within the first 14 days from randomisation and remained recovered until day 28); time to initial alleviation of symptoms (date participant first reported all symptoms as minor or none); time to sustained alleviation of symptoms; time to initial reduction of severity of symptoms; contacts with health services; hospital assessment without admission; oxygen administration; intensive care unit admission; mechanical ventilation; WHO‐5 Well‐Being Index
Notes	Date of publication: 10 August 2021 Sponsor/funding: National Institute of Health Research and United Kingdom Research Innovation

COVID‐19: coronavirus disease 2019; MDI: metered‐dose inhaler; NSAID: non‐steroidal anti‐inflammatory drug; RCT: randomised controlled trial; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; SD: standard deviation; WHO: World Health Organization.