Ramakrishnan 2021.

Study characteristics
Methods	Trial design: randomised, open‐label Type of publication: journal publication Setting: outpatient Recruitment dates: 16 July 2020 to 9 December 2020 Country: UK Language: English Number of centres: not reported Trial registration number: NCT04416399 Date of trial registration: 4 June 2020
Participants	Age: mean: 44 (range 19–71) years in the intervention group 46 (range 19–79) years in the control group Sex: 31 (44%) male and 39 (56%) female in the intervention group 28 (41%) male and 41 (59%) female in the control group Proportion of confirmed infections: positive: 94% in the intervention group and 94% in the control group Ethnicity: white: 65 (93%) in the intervention group and 64 (93%) in the control group; non‐white: 5 (7%) in the intervention group and 5 (7%) in the control group Number of participants (recruited/allocated/evaluated): 146 recruited, of them 73 in the intervention group and 73 in the control group allocated and 70 in the intervention group and 69 in the control group evaluated Severity of condition according to study definition: with symptoms of COVID‐19 (new‐onset cough and fever or anosmia or both) within 7 days Comorbidities: cardiovascular disease, diabetes, past or current asthma Inclusion criteria: willing and able to give informed consent for participation in the trial male or female aged ≥ 18 years new onset of symptoms suggestive of COVID‐19, e.g. new‐onset cough, fever, loss of smell or taste within 7 or fewer days of participant being seen at visit 1 Exclusion criteria: known allergy to investigational medicine product (budesonide) any known contraindication to any of the investigational medicine products (budesonide) currently prescribed inhaled or systemic corticosteroids recent use, within the previous 7 days of inhaled or systemic corticosteroids needs hospitalisation at time of study consent any other significant disease or disorder which, in the opinion of the investigator, may either have put the participants at risk because of participation in the trial, or may have influenced the result of the trial, or the participant's ability to participate in the trial participants who had participated in another research trial involving an investigational product in the past 12 weeks Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): no
Interventions	Intervention group: inhaled budesonide 400 µg per actuation (2 puffs twice per day; total dose 1600 µg) + standard care Control group: standard care Concomitant therapy: antipyretics for symptoms of fever (products containing paracetamol, or NSAIDs such as aspirin and ibuprofen) and honey for symptoms of cough Duration of follow‐up: 14 days Treatment cross‐overs: no Compliance with assigned treatment: yes
Outcomes	Primary outcome: COVID‐19‐related urgent care visits, including emergency department assessment or hospitalisation Secondary outcome: clinical recovery, as defined by self‐reported time to symptom resolution; viral symptoms measured by the Common Cold Questionnaire (CCQ) 12 and the InFLUenza Patient‐Reported Outcome (FLUPro)13 questionnaire; blood oxygen saturations and body temperature; and SARS‐CoV‐2 viral load
Notes	Date of publication: 9 April 2021 Sponsor/funding: National Institute for Health Research Biomedical Research Centre and AstraZeneca