TABLE 1.

Demographics and main clinical variables at randomisation (full analysis set (FAS)), concomitant medications received and adverse events (safety population)

	Usual care n=62	Usual care+budesonide n=58	Total n=120
Demographics (FAS)
Age (years)	51.6±13.8	50.6±13.7	51.1±13.7
Males	32 (51.6%)	24 (42.1%)	56 (47.1%)
Body mass index (kg·m⁻²)	30.1±6.5	28.6±6.0	29.4±6.3
Smoking status
Current	3 (4.8%)	1 (1.8%)	4 (3.4%)
Former	12 (19.4%)	10 (17.5%)	22 (18.5%)
Never	47 (75.8%)	46 (80.7%)	93 (78.2%)
Symptoms (FAS)
Fever	53 (85.5%)	40 (70.2%)	93 (78.2%)
Cough	40 (64.5%)	40 (70.2%)	80 (67.2%)
Arthromyalgia	26 (41.9%)	26 (45.6%)	52 (43.7%)
Anosmia	19 (30.6%)	19 (33.3%)	38 (31.9%)
Ageusia	19 (30.6%)	17 (29.8%)	36 (30.3%)
Diarrhoea	16 (25.8%)	21 (36.8%)	37 (31.1%)
Chest radiography findings (FAS)
Bilateral pneumonia	48 (77.4%)	49 (86.0%)	97 (81.5%)
Unilateral pneumonia	14 (22.6%)	8 (14.0%)	22 (18.5%)
Oxygen requirements at admission (FAS)
None	49 (79.0%)	40 (69.0%)	89 (74.2%)
Low flow	13 (21.0%)	18 (31.0%)	31 (25.8%)
Concomitant medications (safety population)
Enoxaparin	42 (67.7%)	32 (57.1%)	74 (62.7%)
Dexamethasone	13 (21.0%)	6 (10.7%)	19 (16.1%)
Methylprednisolone	1 (1.6%)	1 (1.8%)	2 (1.7%)
Azithromycin	5 (8.1%)	6 (10.7%)	11 (9.3%)
Chloroquine	4 (6.5%)	6 (10.7%)	10 (8.5%)
Remdesivir	4 (6.5%)	6 (10.7%)	10 (8.5%)
Lopinavir/ritonavir	3 (4.8%)	4 (7.1%)	7 (5.9%)
Tocilizumab	1 (1.6%)	0 (0.0%)	1 (0.8%)
Adverse events (safety population)
Any adverse event	21 (33.9%)	20 (35.7%)	41 (34.7%)
Any severe adverse event	3 (4.8%)	2 (3.6%)	5 (4.2%)
Any treatment-related adverse event	0 (0%)	0 (0%)	0 (0%)
Any treatment-related severe adverse event	0 (0%)	0 (0%)	0 (0%)
Mortality at day 30 follow-up	0 (0%)	0 (0%)	0 (0%)
Mortality at day 90 follow-up	1 (1.6%)	1 (1.8%)	2 (1.7%)

Data are presented as n (%) or mean±sd.