Table 1. Demographic and Clinical Characteristics of Participants Included in the Full Analysis Population.*.
| Characteristic | Nirmatrelvir–Ritonavir (N=658) |
Placebo (N=638) |
Total (N=1296) |
|---|---|---|---|
| Sex — no. (%) | |||
| Male | 312 (47.4) | 284 (44.5) | 596 (46.0) |
| Female | 346 (52.6) | 354 (55.5) | 700 (54.0) |
| Median age (range) — yr | 41 (18–87) | 42 (18–82) | 42 (18–87) |
| Race or ethnic group — no. (%)† | |||
| White | 515 (78.3) | 502 (78.7) | 1017 (78.5) |
| Black | 28 (4.3) | 23 (3.6) | 51 (3.9) |
| Asian | 70 (10.6) | 72 (11.3) | 142 (11.0) |
| American Indian or Alaska Native | 39 (5.9) | 32 (5.0) | 71 (5.5) |
| Not reported or unknown | 6 (0.9) | 9 (1.4) | 15 (1.2) |
| Hispanic or Latino | 274 (41.6) | 262 (41.1) | 536 (41.4) |
| Not reported | 4 (0.6) | 6 (0.9) | 10 (0.8) |
| Geographic region — no. (%) | |||
| United States | 216 (32.8) | 206 (32.3) | 422 (32.6) |
| Europe | 222 (33.7) | 215 (33.7) | 437 (33.7) |
| Rest of world | 220 (33.4) | 217 (34.0) | 437 (33.7) |
| Median BMI (range)‡ | 24.9 (17.4–58.8) | 24.9 (14.2–53.1) | 24.9 (14.2–58.8) |
| Vaccinated against Covid-19 — no. (%) | 374 (56.8) | 364 (57.1) | 738 (56.9) |
| Serologic testing for SARS-CoV-2 — no. (%)§ | |||
| Positive | 482 (73.3) | 475 (74.5) | 957 (73.8) |
| Negative | 161 (24.5) | 149 (23.4) | 310 (23.9) |
| Unknown | 15 (2.3) | 14 (2.2) | 29 (2.2) |
| Baseline Covid-19 severity — no. (%)¶ | |||
| None | 8 (1.2) | 11 (1.7) | 19 (1.5) |
| Mild | 205 (31.2) | 178 (27.9) | 383 (29.6) |
| Moderate | 308 (46.8) | 307 (48.1) | 615 (47.5) |
| Severe | 114 (17.3) | 129 (20.2) | 243 (18.8) |
| Missing data | 23 (3.5) | 13 (2.0) | 36 (2.8) |
| Median time from first symptom to start of treatment (range) — days | 3 (0–5) | 3 (0–6) | 3 (0–6) |
| Risk status — no. (%)‖ | |||
| High risk | 319 (48.5) | 317 (49.7) | 636 (49.1) |
| Standard risk | 335 (50.9) | 314 (49.2) | 649 (50.1) |
| Other | 4 (0.6) | 7 (1.1) | 11 (0.8) |
| Most common risk factors — no. (%)** | |||
| BMI ≥30 | 109 (16.6) | 122 (19.1) | 231 (17.8) |
| Smoking | 86 (13.1) | 86 (13.5) | 172 (13.3) |
| Hypertension | 83 (12.6) | 77 (12.1) | 160 (12.3) |
| Diabetes mellitus | 34 (5.2) | 32 (5.0) | 66 (5.1) |
| ≥65 yr of age | 36 (5.5) | 29 (4.5) | 65 (5.0) |
The full analysis population included all participants who underwent randomization, regardless of whether they received the assigned intervention, not including those who were excluded from the analysis because of data-quality issues. Percentages may not total 100 because of rounding. BMI denotes body-mass index, Covid-19 coronavirus disease 2019, and SARS-CoV-2 severe acute respiratory syndrome coronavirus 2.
Race and ethnic group were reported by the participants.
Data were missing for 2 participants in the placebo group.
Participants were considered to be seropositive for SARS-CoV-2 if they had evidence of antibodies to either the nucleocapsid antigen or the spike antigen.
The most severe targeted sign or symptom was considered for this category.
High risk was defined by the presence of one or more risk factors for severe Covid-19, and standard risk was defined by the absence of such risk factors. “Other” includes participants who were at high risk but had never been vaccinated or had not been vaccinated per protocol.
Risk factors occurring in at least 5% of the participants in either group are listed.