Table 1.
Participant demographics and baseline clinical characteristics in the full analysis set
| Tixagevimab–cilgavimab (n=452) | Placebo (n=451) | Total (N=903) | ||
|---|---|---|---|---|
| Age, years | 46·3 (15·4) | 45·9 (15·0) | 46·1 (15·2) | |
| Age group, years | ||||
| ≥18 to <65 | 393 (87%) | 394 (87%) | 787 (87%) | |
| ≥65 to <75 | 38 (8%) | 46 (10%) | 84 (9%) | |
| ≥75 | 21 (5%) | 11 (2%) | 32 (4%) | |
| Sex | ||||
| Female | 239 (53%) | 216 (48%) | 455 (50%) | |
| Male | 213 (47%) | 235 (52%) | 448 (50%) | |
| Ethnicity | ||||
| Hispanic or Latino | 230 (51%) | 238 (53%) | 468 (52%) | |
| Not Hispanic or Latino | 222 (49%) | 213 (47%) | 435 (48%) | |
| Race | ||||
| White | 285 (63%) | 274 (61%) | 559 (62%) | |
| American Indian or Alaska Native | 100 (22%) | 115 (26%) | 215 (24%) | |
| Asian | 30 (7%) | 21 (5%) | 51 (6%) | |
| Black or African American | 16 (4%) | 20 (4%) | 36 (4%) | |
| Unknown, not reported, multiple, or missing data | 21 (5%) | 21 (5%) | 42 (5%) | |
| Body-mass index, kg/m2 | 28·9 (5·5) | 29·2 (6·6) | 29·0 (6·0) | |
| Time from symptom onset, days | 4·9 (1·6) | 5·0 (1·6) | 5·0 (1·6) | |
| Serum for SARS-CoV-2 serology | ||||
| Positive | 60 (13%) | 67 (15%) | 127 (14%) | |
| Negative | 384 (85%) | 374 (83%) | 758 (84%) | |
| Missing data | 8 (2%) | 10 (2%) | 18 (2%) | |
| At high risk of progression to severe COVID-19* | 404 (89%) | 405 (90%) | 809 (90%) | |
| Risk factors for severe COVID-19 | ||||
| One or more risk factor | 400 (89%) | 399 (89%) | 799 (89%) | |
| Obesity, body mass-index >30 kg/m2 | 195 (43%) | 193 (43%) | 388 (43%) | |
| Smoking | 180 (40%) | 184 (41%) | 364 (40%) | |
| Hypertension | 135 (30%) | 121 (27%) | 256 (28%) | |
| Diabetes | 53 (12%) | 55 (12%) | 108 (12%) | |
| Chronic lung disease or asthma | 58 (13%) | 50 (11%) | 108 (12%) | |
| Cardiovascular disease | 42 (9%) | 38 (8%) | 80 (9%) | |
| Cancer | 18 (4%) | 15 (3%) | 33 (4%) | |
| Chronic kidney disease | 10 (2%) | 9 (2%) | 19 (2%) | |
| Chronic liver disease | 7 (2%) | 13 (3%) | 20 (2%) | |
| Immunocompromised state | 22 (5%) | 23 (5%) | 45 (5%) | |
Data are mean (SD) or n (%).
*
High risk of progression defined as at least one risk factor, including age (≥65 years old) or having at least one comorbidity (cancer, chronic lung disease, obesity, hypertension, cardiovascular disease, diabetes, chronic kidney disease, chronic liver disease, immunocompromised state, sickle cell disease, or smoking).