Table 2.
Primary and supportive endpoints in the intention to treat population
| Number included | IL-1 blockade group (95% CI) | No IL-1 blockade group (95% CI) | HR or expected count ratio (95% CI) | IL-6 blockade group (95% CI) | No IL-6 blockade group (95% CI) | HR or expected count ratio (95% CI) | |
|---|---|---|---|---|---|---|---|
| Primary endpoint | |||||||
| Median time until clinical improvement | 342 | 12 days (10–16) | 12 days (10–15) | 0·94 (0·73–1·21) | 11 days (10–16) | 12 days (11–16) | 1·00 (0·78–1·29) |
| Estimated probability of having experienced clinical improvement at day 28 | 342 | 75% (67–83) | 73% (67–79) | .. | 74% (68–79) | 74% (66–82) | .. |
| Supportive endpoints | |||||||
| Median time until discharge | 342 | 14 days (11–19) | 12 days (11–18) | 0·90 (0·70–1·16) | 12 days (11–18) | 13 days (11–19) | 1·02 (0·80–1·31) |
| Median time until independence from supplemental oxygen or discharge | 336 | 12 days (10–20) | 12 days (10–15) | 0·91 (0·71–1·17) | 11 days (10–15) | 12 days (10–15) | 1·00 (0·78–1·28) |
| Median time until independence from invasive ventilation | 39 | 21 days (8–NE) | 27 days (9–NE) | 1·21 (0·54–2·71) | 23 days (8–NE) | 54 days (9–NE) | 1·45 (0·63–3·33) |
| Median time until first use of high-flow oxygen device, ventilation, or death | 175 | <50% reached event | <50% reached event | 0.97 (0·52–1·82) | <50% reached event | <50% reached event | 0·85 (0·47–1·55) |
| Number of days in hospital | 336 | 19 days (17–22) | 19 days (17–21) | 1·01 (0·85–1·21) | 20 days (18–22) | 19 days (16–22) | 1·03 (0·86–1·22) |
| Number of days in ICU | 336 | 11 days (8–15) | 10 days (8–13) | 1·05 (0·69–1·59) | 11 days (8–14) | 10 days (7–15) | 1·03 (0·68–1·56) |
| Number of days in ICU in patients ventilated at day of randomisation | 39 | 20 days (15–27) | 22 days (17–29) | 0·89 (0·60–1·32) | 20 days (16–27) | 22 days (16–29) | 0·94 (0·64–1·40) |
| Number of days in ICU, relative to number of days alive the first 28 days after randomisation | 336 | 42% (31–56) | 36% (29–46) | 1·14 (0·79–1·66) | 38% (30–48) | 40% (29–54) | 0·96 (0·66–1·39) |
| Number of days without supplemental oxygen use up to 28 days after randomisation | 337 | 9 days (7–12) | 9 days (7–11) | 0·97 (0·68–1·38) | 10 days (8–12) | 8 days (6–11) | 1·17 (0·82–1·68) |
| Number of invasive ventilator days | 337 | 5 days (3–9) | 5 days (3–7) | 1·05 (0·54–2·03) | 5 days (3–7) | 5 days (3–9) | 0·89 (0·46–1·72) |
| Number of invasive ventilator days in patients ventilated at day of randomisation | 39 | 15 days (11–20) | 16 days (13–21) | 0·93 (0·63–1·37) | 15 days (12–20) | 16 days (12–22) | 0·96 (0·65–1·42) |
| Number of invasive ventilator days, relative to number of days alive the first 28 days after randomisation | 337 | 23% (14–38) | 21% (14–31) | 1·08 (0·57–2·05) | 21% (14–30) | 23% (14–38) | 0·89 (0·47–1·70) |
| Number of invasive ventilator-free days up to 28 days after randomisation | 337 | 18 days (15–21) | 18 days (16–20) | 1·00 (0·84–1·19) | 18 days (17–20) | 17 days (15–20) | 1·07 (0·90–1·27) |
| Number of invasive ventilator-free days up to 28 days after randomisation in patients ventilated at day of randomisation | 39 | 6 days (3–14) | 6 days (3–13) | 1·01 (0·33–3·07) | 7 days (4–15) | 5 days (2–12) | 1·39 (0·46–4·20) |
Data are n, median time until events (95% CI) with HR (95% CI) or mean number of days (95% CI) with expected count ratio or mean ratio (95% CI). IL=interleukin. HR=hazard ratio. NE=not estimable. ICU=intensive care unit.