TABLE 1.
Baseline characteristics
| Part 1 | Part 2 | |||||
| Overall population | Age 70–79 years# | Overall population | ||||
| Characteristic | Otilimab (N=403) | Placebo (N=403) | Otilimab (n=88) | Placebo (n=92) | Otilimab (N=175) | Placebo (N=175) |
| Male sex | 302 (75) | 275 (68) | 65 (74) | 57 (62) | 102 (58) | 100 (57) |
| Age | 59.8±11.7 | 59.4±11.9 | 74.0±2.8 | 74.0±2.8 | 75.3±4.7 | 75.0±4.7 |
| Age group | ||||||
| Part 1: | ||||||
| <60 years | 178 (44) | 185 (46) | 0 | 0 | – | – |
| 60–69 years | 135 (33) | 127 (32) | 0 | 0 | – | – |
| 70–79 years | 90 (22) | 91 (23) | 88 (100) | 92 (100) | – | – |
| Part 2: | ||||||
| <70 years¶ | – | – | – | – | 9 (5) | 5 (3) |
| 70–79 years | – | – | – | – | 126 (72) | 136 (78) |
| ≥80 years | – | – | – | – | 40 (23) | 34 (19) |
| Weight (kg) | 88.0±20.9 | 88.2±20.9 | 84.6±20.2 | 80.0±14.2 | 83.9±16.2 | 81.9±16.5 |
| Race or ethnic group | ||||||
| American Indian or Alaska Native | 30 (8) | 24 (6) | 3 (3) | 4 (4) | 8 (5) | 3 (2) |
| Asian | 57 (14) | 73 (19) | 12 (14) | 18 (20) | 5 (3) | 15 (9) |
| Black or African American | 26 (7) | 25 (6) | 5 (6) | 3 (3) | 6 (3) | 6 (3) |
| White | 272 (69) | 262 (67) | 67 (77) | 64 (71) | 155 (89) | 150 (86) |
| Hispanic or Latino | 125 (31) | 116 (29) | 13 (15) | 18 (20) | 58 (33) | 37 (21) |
| Clinical status | ||||||
| Category 5: Hospitalised, high-flow oxygen, noninvasive ventilation | 311 (77) | 311 (77) | 63 (72) | 68 (74) | 150 (86) | 148 (85) |
| Category 6: Hospitalised, mechanical ventilation | 89 (22) | 89 (22) | 24 (27) | 23 (25) | 25 (14) | 27 (15) |
| ICU status | ||||||
| Not in ICU and not on mechanical ventilation | 97 (24) | 98 (24) | 13 (15) | 17 (18) | 79 (45) | 83 (47) |
| In ICU and not on mechanical ventilation | 209 (52) | 211 (52) | 49 (56) | 52 (57) | 69 (39) | 62 (35) |
| In ICU and on mechanical ventilation | 97 (24) | 94 (23) | 26 (30) | 23 (25) | 27 (15) | 30 (17) |
| Biomarkers + | ||||||
| CRP (mg·L−1) | 111.8±86.0 | 116.3±84.5 | 109.7±79 | 128.8±82.2 | 96.1±79.4 | 93.5±77.7 |
| Ferritin (μg·L−1) | 1247.7±1242.9 | 1147.4±1041.6 | 1493.1±1916 | 1248.4±1201.3 | 1482.3±1697.3 | 1177.4±1060.7 |
| GM-CSF (ng·L−1) | 0.71±0.84 | 0.72±0.76 | 0.82±1.19 | 0.73±0.71 | 0.82±1.44 | 0.80±0.95 |
| Residence prior to hospital admission | ||||||
| Independent or community dwelling | 392 (98) | 391 (97) | NA | NA | 173 (99) | 169 (97) |
| Long-term care facility | 7 (2) | 10 (2) | NA | NA | 2 (1) | 6 (3) |
| Current comorbidity § | ||||||
| Hypertension | 192 (48) | 209 (52) | 59 (67) | 61 (66) | 113 (65) | 129 (74) |
| Diabetes | 147 (36) | 149 (37) | 31 (35) | 39 (42) | 57 (33) | 63 (36) |
| Hyperlipidaemia | 97 (24) | 96 (24) | 35 (40) | 41 (45) | 45 (26) | 53 (30) |
| Heart disorder | 51 (13) | 45 (11) | 21 (24) | 21 (23) | 35 (20) | 47 (27) |
| Pretreatment medications § ,ƒ | ||||||
| Corticosteroids (including dexamethasone) | 332 (84) | 330 (83) | 72 (82) | 74 (80) | 150 (86) | 148 (86) |
| Dexamethasone | 281 (71) | 267 (67) | 64 (73) | 66 (72) | 137 (79) | 125 (72) |
| Remdesivir | 127 (32) | 142 (36) | 28 (32) | 32 (35) | 12 (7) | 22 (13) |
| Convalescent plasma therapy | 20 (5) | 24 (6) | 5 (6) | 4 (4) | NA | NA |
| Immunosuppressants | 0 | 0 | 0 | 0 | 1 (<1) | 0 |
| Anti-IL-6 therapies | 0 | 0 | 0 | 0 | 1 (<1)## | 0 |
| Antiviral | 136 (34) | 155 (39) | 29 (33) | 38 (41) | 29 (17) | 44 (25) |
| COVID-19 vaccine | NA | NA | NA | NA | 2 (4) | 1 (2) |
| Geographic region § | ||||||
| USA | 98 (24) | 90 (22) | 20 (23) | 23 (25) | 1 (<1) | 6 (3) |
| Europe¶¶ | 142 (35) | 160 (40) | 41 (47) | 38 (41) | 69 (39) | 78 (45) |
| Latin America++ | 68 (17) | 53 (13) | 8 (9) | 8 (9) | 53 (30) | 31 (18) |
| Rest of world§§ | 95 (24) | 100 (25) | 19 (22) | 23 (25) | 44 (25) | 49 (28) |
Data are presented as n (%) or mean±sd. ICU: intensive care unit; CRP: C-reactive protein; GM-CSF: granulocyte–macrophage colony-stimulating factor; IL: interleukin; NA: not available. #: baseline characteristics in the Part 1 age 70–79 years subgroup are presented in the modified intent-to-treat population; ¶: patient age was derived from the date of screening visit, year of birth (provided at screening) and an assumed birth date of June 30, and so some patients were recorded as <70 years; +: biomarkers summarised by actual treatment received; §: data in the Part 1 age 70–79 years group are from Day 4; ƒ: a dose or infusion of medication used prior to Day 1 (day of dosing of study drug), irrespective of whether medication continued after dosing; ##: one patient who had received anti-IL-6 therapy was included in error; ¶¶: Belgium, France, Italy, Netherlands, Poland, Spain, UK; ++: Argentina, Brazil, Chile, Colombia, Mexico, Peru; §§: Canada, India, Japan, Russian Federation, South Africa.