Table 1.
Baseline patient characteristics
| All patients (N=416) | Placebo (n=84) | Sarilumab 200 mg (n=159) | Sarilumab 400 mg (n=173) | ||
|---|---|---|---|---|---|
| Age, years | 59·0 (50·0–68·0) | 60·0 (53·0–69·5) | 58·0 (51·0–67·0) | 58·0 (48·0–67·0) | |
| Sex | |||||
| Men | 261 (63%) | 54 (64%) | 108 (68%) | 99 (57%) | |
| Women | 155 (37%) | 30 (36%) | 51 (32%) | 74 (43%) | |
| Race | |||||
| Asian | 20 (5%) | 6 (7%) | 5 (3%) | 9 (5%) | |
| Black | 9 (2%) | 1 (1%) | 3 (2%) | 5 (3%) | |
| White | 321 (77%) | 67 (80%) | 126 (79%) | 128 (74%) | |
| Other* | 66 (16%) | 10 (12%) | 25 (16%) | 31 (18%) | |
| Ethnicity | |||||
| Hispanic or Latino | 150† (36%) | 31 (37%) | 53 (33%) | 66 (38%) | |
| Weight, kg | 83·0 (74·0–98·0) | 83·4 (72·0–97·4) | 83·0 (74·0–98·0) | 83·5 (74·0–98·0) | |
| Body-mass index ≥30 kg/m2 | 147/350 (42%) | 29/69 (42%) | 55/133 (41%) | 63/148 (43%) | |
| Comorbidities | |||||
| Hypertension | 177 (43%) | 39 (46%) | 68 (43%) | 70 (40%) | |
| Diabetes | 110 (26%) | 18 (21%) | 45 (28%) | 47 (27%) | |
| Obesity | 86 (21%) | 12 (14%) | 37 (23%) | 37 (21%) | |
| Neoplasm‡ | 42 (10%) | 6 (7%) | 17 (11%) | 19 (11%) | |
| Dyslipidaemia | 41 (10%) | 6 (7%) | 16 (10%) | 19 (11%) | |
| Coronary artery disease | 22 (5%) | 6 (7%) | 7 (4%) | 9 (5%) | |
| Chronic obstructive pulmonary disease | 18 (4%) | 6 (7%) | 4 (3%) | 8 (5%) | |
| Asthma | 17 (4%) | 3 (4%) | 10 (6%) | 4 (2%) | |
| Chronic kidney disease | 18 (4%) | 5 (6%) | 7 (4%) | 6 (3%) | |
| Severity of illness | |||||
| Severe§ | 252 (61%) | 55 (65%) | 92 (58%) | 105 (61%) | |
| Critical¶ | 162 (39%) | 29 (35%) | 65 (41%) | 68 (39%) | |
| Multisystem organ dysfunction | 2 (<1%) | 0 | 2 (1%) | 0 | |
| Clinical status on seven-point scale | |||||
| 2 | 50 (12%) | 9 (11%) | 17 (11%) | 24 (14%) | |
| 3 | 60 (14%) | 11 (13%) | 28 (18%) | 21 (12%) | |
| 4 | 304 (73%) | 64 (76%) | 112 (70%) | 128 (74%) | |
| 5 | 2 (<1%) | 0 | 2 (1%) | 0 | |
| Signs and symptoms | |||||
| Body temperature, °C‖ | 38·1 (0·9) | 38·0 (0·9) | 38·1 (0·9) | 38·2 (1·0) | |
| Fever** | 218 (52%) | 36 (43%) | 84 (53%) | 98 (57%) | |
| Cough | 298 (72%) | 58 (69%) | 112 (70%) | 128 (74%) | |
| Dyspnoea | 357 (86%) | 75 (89%) | 131 (82%) | 151 (87%) | |
| Time from dyspnoea onset to baseline, days | 5·0 (2·0–9·0) | 7·0 (3·0–10·0) | 5·0 (2·0–10·0) | 4·0 (2·0–9·0) | |
| Duration of hospital stay before dosing, days | 3·0 (2·0–4·0) | 4·0 (2·0–6·0) | 3·0 (1·0–4·0) | 2·0 (2·0–4·0) | |
| Admitted to ICU before dosing | 148 (36%) | 28 (33%) | 61 (38%) | 59 (34%) | |
| Duration of ICU stay before dosing, days | 2·0 (1·0–3·0) | 1·0 (1·0–3·5) | 2·0 (1·0–3·0) | 2·0 (1·0–3·0) | |
| Oxygen flow rate, L/min | 5·0 (3·0–8·0) | 5·0 (2·0–7·0) | 5·0 (3·0–9·0) | 5·0 (3·0–7·0) | |
| Percentage SpO2 | 95·0% (93·0–96·0) | 94·0% (93·0–96·0) | 95·0% (93·0–96·0) | 94·0% (93·0–96·0) | |
| Percentage FiO2 | 40·0% (32·0–55·0) | 40·0% (28·0–50·0) | 40·0% (32·0–60·0) | 40·0% (32·0–55·0) | |
| SpO2 to FiO2 ratio | 237·5 (173·6–300·0) | 240·0 (190·0–332·1) | 230·0 (165·0–296·9) | 237·5 (172·7–293·8) | |
| Type of oxygen delivery device | |||||
| Nasal cannula | 175 (42%) | 41 (49%) | 67 (42%) | 67 (39%) | |
| Simple face mask | 111 (27%) | 21 (25%) | 44 (28%) | 46 (27%) | |
| Non-rebreather face mask | 44 (11%) | 8 (10%) | 12 (8%) | 24 (14%) | |
| High-flow nasal cannula | 26 (6%) | 3 (4%) | 14 (9%) | 9 (5%) | |
| Non-invasive ventilation | 7 (2%) | 2 (2%) | 3 (2%) | 2 (1%) | |
| Invasive mechanical ventilation | 48 (12%) | 9 (11%) | 16 (10%) | 23 (13%) | |
| Other | 5 (1%) | 0 | 3 (2%) | 2 (1%) | |
| Use of extracorporeal membrane oxygenation | 0 | 0 | 0 | 0 | |
| Use of renal replacement therapy | 2 (<1%) | 0 | 2 (1%) | 0 | |
| Use of vasopressors | 12 (3%) | 1 (1%) | 5 (3%) | 6 (3%) | |
| Systemic corticosteroid use before dosing | 83 (20%) | 16 (19%) | 25 (16%) | 42 (24%) | |
| Laboratory findings | |||||
| SARS-CoV-2 virus detected†† | 391 (94%) | 80 (95%) | 147 (92%) | 164 (95%) | |
| C-reactive protein, mg/L | 94·6 (48·1–167·9) | 95·5 (55·5–184·4) | 94·1 (44·6–176·8) | 96·1 (48·1–160·6) | |
| IL-6, pg/mL | 12·3 (4·8–25·5) | 13·0 (3·6–23·5) | 11·6 (5·1–23·5) | 12·7 (5·5–26·5) | |
| Soluble IL-6 receptor, ng/mL | 42·4 (33·4–58·0) | 43·8 (32·1–61·8) | 41·2 (33·7–59·2) | 43·0 (33·7–54·4) | |
| D-dimer, mg/L | 0·50 (0·20–0·99) | 0·53 (0·17–1·14) | 0·48 (0·23–1·02) | 0·54 (0·16–0·97) | |
| Ferritin, μg/L | 765·0 (437·5–1309·0) | 979·6 (458·0–1644·0) | 694·6 (477·5–1270·5) | 737·0 (375·5–1151·0) | |
| Neutrophil to lymphocyte ratio | 5·3 (3·5–9·2) | 5·5 (3·8–8·8) | 5·1 (3·5–9·8) | 5·4 (3·4–8·5) | |
Data are median (IQR), n (%), n/N (%), or mean (SD). FiO2=fractional concentration of oxygen in inspired air. ICU=intensive care unit. IL-6=interleukin 6. SpO2=oxygen saturation.
Includes race not reported, other, or unknown.
136 (91%) of 150 Hispanic or Latino patients were in the white race category.
Includes benign, malignant, and unspecified neoplasms.
Severe disease was defined by supplemental oxygen administration by nasal cannula, simple face mask, or another similar device.
Critical disease was defined by one of the following criteria: supplemental oxygen delivered by non-rebreather mask or high-flow nasal cannula, use of invasive or non-invasive ventilation, or treatment in an ICU.
Defined as the highest temperature during the screening period.
Defined as body temperature greater than 37·4°C (axilla), greater than 38·0°C (oral), or greater than 38·4°C (rectal or tympanic).
Based on nasopharyngeal or serum PCR samples collected before first infusion.