NCT05055414.

Study name	Arformoterol/budesonide for COVID‐19 (ABC)
Methods	Trial design: randomised, controlled, triple‐blind trial Sample size: 140 Setting: unclear, probably outpatient Language: English Number of centres: not reported Type of intervention (treatment/prevention): treatment
Participants	Inclusion criteria: adults aged ≥ 19 years new onset of symptoms suggestive of COVID‐19 (fever, cough, sore throat, etc.) or diagnosed with COVID‐19 within 7 days of participant being seen at visit 1 in the Investigator's opinion, is able and willing to comply with all trial requirements Exclusion criteria: a condition requiring invasive oxygen support history of hypersensitivity to budesonide and arformoterol pregnancy, breastfeeding participation in other clinical studies within 4 weeks prior to enrolment in this study refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient
Interventions	Intervention group: inhaled budesonide/arformoterol dry powder inhaler 3 inhalations twice daily at 3 days and 2 inhalations twice daily at 11 days Control group: placebo for 2 weeks Concomitant therapy: no
Outcomes	Primary outcome: time to clinical improvement on WHO Ordinal Scale at 28 days Secondary outcomes: WHO Ordinal Scale for Clinical Improvement at 28 days; WHO Ordinal Scale change at 28 days; clinical cure rate at 28 days
Starting date	1 November 2021
Contact information	Korea United Pharm Inc.
Notes	Recruitment status: not yet recruiting Prospective completion date: 1 October 2022 Date last update was posted: 24 September 2021 Sponsor/funding: Korea United Pharm. Inc.

ALT: alanine aminotransferase; AST: aspartate aminotransferase; BMI: body mass index; COPD: chronic obstructive pulmonary disease; COVID‐19: coronavirus disease 2019; CRP: C‐reactive protein; CT: computer tomography; GFR: glomerular filtration rate; HFNC: high flow nasal cannula; INR: international normalised ratio; NIV: non‐invasive ventilation; PCR: polymerase chain reaction; PCT: procalcitonin; RCT: randomised controlled trial; RT‐PCR: real‐time polymerase chain reaction; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2; WHO: World Health Organization.