Characteristic |
Overall N=778 |
Proxalutamide N=423 |
Placebo N=355 |
p-value |
Age |
|
|
|
|
Median – years (IQR) |
51 (41-62) |
52 (42-62) |
51 (39-62) |
0.062 |
> 55 yr – no. (%) |
296 (38.0%) |
159 (37.6%) |
137 (38.6%) |
0.77 |
Sex – no. (%) |
|
|
|
0.26 |
Female |
314 (40.4%) |
163 (38.5%) |
151 (42.5%) |
|
Male |
464 (59.6%) |
260 (61.5%) |
204 (57.5%) |
|
Comorbidities |
|
|
|
|
Body mass index over 30 kg/m2 – no. (%) |
68 (8.7%) |
39 (9.2%) |
29 (8.2%) |
0.70 |
Hypertension – no. (%) |
215 (27.6%) |
124 (29.3%) |
91 (25.6%) |
0.26 |
Type 2 diabetes mellitus – no. (%) |
97 (12.5%) |
55 (13.0%) |
42 (11.8%) |
0.055 |
Chronic obstructive pulmonary disorder – no. (%) |
18 (2.3%) |
9 (2.1%) |
9 (2.5%) |
0.81 |
Chronic kidney disease – no. (%) |
0 |
0 |
0 |
n/a |
Coexisting conditions – no. (%) |
|
|
|
|
0 |
507 (65.2%) |
267 (63.1%) |
240 (67.6%) |
0.19 |
1 |
157 (20.2%) |
92 (21.7%) |
65 (18.3%) |
0.26 |
2+ |
114 (14.6%) |
64 (15.1%) |
50 (14.1%) |
0.68 |
Median time from hospitalization to randomization (IQR) – days |
2 (1-4) |
2 (1-4) |
2 (1-4) |
0.16 |
Score on the Coronavirus Disease 2019 ordinal scale – no. (%) |
|
|
|
|
3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care |
2 (0.3%) |
0 |
2 (0.6%) |
0.25 |
4. Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) |
24 (3.1%) |
12 (2.8%) |
12 (3.3%) |
0.66 |
5. Hospitalized, requiring supplemental oxygen |
252 (31.4%) |
136 (32.2%) |
116 (32.7%) |
0.88 |
6. Hospitalized, receiving non-invasive ventilation or high flow oxygen devices |
500 (64.3%) |
275 (65.0%) |
225 (63.4%) |
0.64 |