NCT04331054.

Methods	Trial design: open‐label, RCT Sample size: 146 Setting: inpatient Language: English Number of centres: not reported Type of intervention: treatment
Participants	Inclusion criteria: aged ≥ 18 years and ≤ 75 years laboratory‐confirmed infection by COVID‐19 by RT‐PCR on a respiratory biological sample within 2 days hospitalisation required according to current local recommendations patient affiliated to a social security regimen able to give free, informed, and written consent Exclusion criteria: oxygen flow rate > 8 L/minute at inclusion current treatment with any inhaled steroid (any other form of steroid administration does not exclude the patient) ICU required (based on investigator judgement) with cognitive impairment that does not guarantee proper use of the treatment by the patients themselves pregnant (positive β‐human chorionic gonadotropin at inclusion) or breastfeeding women participation in another interventional drug study involving humans and concerning COVID‐19 infection or being in the exclusion period of a previous study involving humans contraindications to treatments (history of hypersensitivity) admitted for isolation, for social reason or due to comorbidities without gravity sign long‐term patient treated with digitalis, disopyramide, procainamide, or phenothiazine that could lengthen the QT space
Interventions	Intervention group: inhaled SYMBICORT RAPIHALER 2 puffs twice daily for 30 days + standard care Control group: standard care Concomitant therapy: no
Outcomes	Primary outcomes: time (in days) to clinical improvement within 30 days after randomisation, defined as the time from randomisation to an improvement of 2 points (from the status at randomisation) on a 7‐category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The 7‐category ordinal scale consisted of the following categories: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal activities Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high‐flow oxygen therapy, non‐invasive mechanical ventilation, or both; Hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both Death These parameters will be evaluated daily during hospitalisations. Secondary outcomes: mortality rate at day 30; time (in days) from randomisation to death up to 30 days; number of days alive outside ICU within 30 days; number of days alive free of invasive or non‐invasive ventilation within 30 days; number of days alive with oxygen therapy within 30 days; maximal oxygen rate within 30 days; difference between PaO2/FiO2 ratio at randomisation and day 7 (or at the time of stopping oxygen therapy or discharge if occurs before day 7); number of days alive outside hospital within 30 days; use of antibiotics for respiratory (confirmed or suspected) infection within 30 days; difference between C‐reactive protein levels at randomisation and day 7 (or at the time of discharge if occurs before day 7) Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment up to 30 days after randomisation
Notes	Recruitment status: terminated (insufficient recruitment) Prospective completion date: 28 May 2021 Date last update was posted: 3 August 2021 Sponsor/funding: Assistance Publique – Hôpitaux de Paris