TABLE 1.
Baseline Demographic and Clinical Characteristics
| Characteristic | Placeboa (n = 134) | Astegolimab (n = 130) | Efmarodocokin Alfa (n = 132) | All Patients (n = 396) |
|---|---|---|---|---|
| Age | ||||
| Median (range), yr | 57 (26–89) | 58 (29–94) | 57 (27–86) | 57 (26–94) |
| Sex, n (%) | ||||
| Female | 45 (34) | 56 (43) | 52 (39) | 153 (39) |
| Male | 89 (66) | 74 (57) | 80 (61) | 243 (61) |
| Clinical statusb, n (%) | ||||
| 2 | 3 (2) | 4 (3.08) | 1 (0.76) | 8 (2.02) |
| 3 | 47 (35) | 49 (38) | 57 (43) | 153 (39) |
| 4 | 71 (53) | 64 (49) | 63 (48) | 198 (50) |
| 5 | 10 (7) | 8 (6) | 8 (6) | 26 (7) |
| 6 | 3 (2) | 4 (3) | 2 (2) | 9 (2) |
| Not available | 0 | 1 (1) | 1 (1) | 2 (1) |
| Baseline mechanical ventilation, n (%) | ||||
| No | 122 (91) | 117 (90) | 121 (92) | 360 (91) |
| Yes | 12 (9) | 13 (10) | 11 (8) | 36 (9) |
| Duration of hospitalization at randomization | ||||
| Mean (range), d | 4.14 (1–15) | 4.47 (1–16) | 4.55 (1–20) | 4.38 (1–20) |
| ICU admission, n (%) | ||||
| Admitted to ICU at randomization | 63 (47) | 58 (45) | 47 (36) | 168 (42) |
| Not admitted to ICU at randomization | 71 (53) | 72 (55) | 85 (64) | 228 (58) |
| Duration of COVID-19 diagnosis at randomization | ||||
| n | 133 | 130 | 132 | 395 |
| Mean (range), d | 5.33 (1–16) | 5.89 (1–15) | 5.9 (1–19) | 5.71 (1–19) |
| Duration of COVID-19 symptoms at randomization | ||||
| n | 133 | 129 | 132 | 394 |
| Mean (range), d | 11.59 (1–42) | 11.38 (1–24) | 11.58 (1–26) | 11.52 (1–42) |
| C-reactive protein | ||||
| n | 122 | 120 | 126 | 368 |
| mg/L, mean ± sd | 79.9 ± 64.8 | 77.3 ± 90.1 | 81.7 ± 71.7 | 79.7 ± 76.0 |
| Remdesivir treatment on study, n (%) | 78 (58.2) | 74 (56.9) | 75 (56.8) | 227 (57.3) |
| Tocilizumab treatment on study, n (%) | 16 (11.9) | 18 (13.8) | 13 (9.8) | 47 (11.9) |
| Steroid use on study, n (%) | 126 (94.0) | 129 (99.2) | 126 (95.5) | 381 (96.2) |
Matching placebo groups for astegolimab and efmarodocokin alfa were pooled for all analyses.
Clinical status was defined by the 7-category ordinal scale: 1, discharged (or “ready for discharge” as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤ 2 L supplemental oxygen); 2, non-ICU hospital ward (or “ready for hospital ward”) not requiring supplemental oxygen; 3, non-ICU hospital ward (or “ready for hospital ward”) requiring supplemental oxygen; 4, ICU or non-ICU hospital ward, requiring noninvasive ventilation or high-flow oxygen; 5, ICU, requiring intubation and mechanical ventilation; 6, ICU, requiring extracorporeal membrane oxygenation or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy); 7, death.