Table 1. Baseline Characteristics of the Patients in the Immune Modulation Therapy Domain.*.
| Characteristic | Tocilizumab (N=353) |
Sarilumab (N=48) |
Control (N=402)† |
All Patients (N=865)‡ |
|---|---|---|---|---|
| Age — yr | 61.5±12.5 | 63.4±13.4 | 61.1±12.8 | 61.4±12.7 |
| Male sex — no. (%) | 261 (74) | 39 (81) | 283 (70) | 629 (73) |
| Race or ethnic group — no./total no. (%)§ | ||||
| White | 160/228 (70) | 29/39 (74) | 206/279 (74) | 420/580 (72) |
| Asian | 41/228 (18) | 8/39 (21) | 47/279 (17) | 99/580 (17) |
| Black | 12/228 (5) | 1/39 (3) | 9/279 (3) | 23/580 (4) |
| Mixed | 2/228 (1) | 0/39 | 5/279 (2) | 7/580 (1) |
| Other | 13/228 (6) | 1/39 (3) | 12/279 (4) | 31/580 (5) |
| Body-mass index¶ | ||||
| Patients evaluated | 342 | 39 | 377 | 815 |
| Median (IQR) | 30.5 (26.9–34.9) | 29.2 (26.0–33.8) | 30.9 (27.1–34.9) | 30.5 (26.8–34.9) |
| APACHE II score‖ | ||||
| Patients evaluated | 337 | 42 | 381 | 820 |
| Median (IQR) | 13 (8–19) | 10 (7–16) | 12 (8–18) | 12 (8–19) |
| Confirmed SARS-CoV-2 infection — no./total no. (%)** | 284/345 (82) | 44/47 (94) | 334/394 (85) | 715/847 (84) |
| Median time to enrollment (IQR) | ||||
| From hospital admission — days | 1.2 (0.8–2.8) | 1.4 (0.9–2.8) | 1.2 (0.8–2.8) | 1.2 (0.8–2.8) |
| From ICU admission — hr | 13.1 (6.6–19.0) | 16.0 (11.4–20.8) | 14.0 (6.8–19.5) | 13.6 (6.6–19.4) |
| Acute respiratory support — no./total no. (%) | ||||
| None or supplemental oxygen only | 1/353 (<1) | 0/48 | 2/402 (<1) | 3/865 (<1) |
| High-flow nasal cannulae | 101/353 (29) | 17/48 (35) | 110/402 (27) | 249/865 (29) |
| Noninvasive ventilation only | 147/353 (42) | 23/48 (48) | 169/402 (42) | 359/865 (42) |
| Invasive mechanical ventilation | 104/353 (29) | 8/48 (17) | 121/402 (30) | 254/865 (29) |
| Vasopressor support — no./total no. (%) | 63/353 (18) | 4/48 (8) | 79/402 (20) | 163/865 (19) |
| Pao2:Fio2 | ||||
| Patients evaluated | 335 | 35 | 354 | 780 |
| Median (IQR) | 115 (89–162) | 126 (99–157) | 118 (89–169) | 116.5 (89–165) |
| Laboratory values†† | ||||
| C-reactive protein | ||||
| Patients evaluated | 207 | 37 | 244 | 533 |
| Median (IQR) — μg/ml | 150 (85–221) | 136 (105–204) | 130 (71–208) | 136 (79–208) |
| d-dimer | ||||
| Patients evaluated | 159 | 20 | 172 | 385 |
| Median (IQR) — ng/ml | 832 (461–1763) | 828 (355–1435) | 1010 (500–2115) | 910 (480–1916) |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding. Fio2 denotes the fraction of inspired oxygen, ICU intensive care unit, IQR interquartile range, and Pao2 the partial pressure of arterial oxygen.
Control patients include all the patients randomly assigned to standard care who were also eligible to be randomly assigned to tocilizumab or sarilumab (i.e., direct concurrent controls).
All patient includes those who underwent randomization in the Immune Modulation Therapy domain, with assignment to control (including where tocilizumab and sarilumab were not randomization options; i.e., nondirect controls), tocilizumab, sarilumab, anakinra, or interferon beta-1a.
Race and ethnic group were reported by the patients. Data collection was not approved in Canada and continental Europe. “Other” includes “declined” and “multiple.”
The body-mass index is the weight in kilograms divided by the square of the height in meters.
Scores on the Acute Physiology and Chronic Health Evaluation (APACHE) II range from 0 to 71, with higher scores indicating greater severity of illness.
Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was confirmed by a respiratory tract polymerase-chain-reaction test.
Values were from the sample collected closest to randomization, up to 8 hours before randomization. If no samples were collected up to 8 hours before the time of randomization, the sample collected closest to the time of randomization up to 2 hours after randomization was used (other than for Pao2:Fio2, which was a prerandomization value only). Laboratory values were only added to the case-report form on August 6, 2020.