Table 2.
Primary and secondary outcomes
| IVIG group (n=69) | Placebo group (n=77) | Difference (95% CI)* | Unadjusted odds ratio (95% CI) | p value | ||
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| Median number of ventilation-free days at 28 days | 0·0 (0·0 to 8·0) | 0·0 (0·0 to 6·0) | 0·0 (0·0 to 0·0) | .. | 0·21† | |
| Mean number of ventilation-free days at 28 days | 6·7 (4·6 to 8·8) | 7·0 (4·9 to 9·2) | 0·5 (−3·5 to 2·5) | .. | .. | |
| Competing risk | ||||||
| Death at 28 days | 24 (35%) | 20 (26%) | .. | 1·52 (0·75 to 3·09) | 0·25 | |
| Patients receiving mechanical ventilation at day 28 | 15 (22%) | 22 (29%) | .. | 1·44 (0·67 to 3·07) | 0·35 | |
| Median time to last extubation (days)‡ | 12·5 (8·0 to 18·0) | 9·5 (7·0 to 18·0) | 1·0 (−3·0 to 4·0) | .. | 0·38 | |
| Prespecified secondary outcomes | ||||||
| Median lung injury score at day 28§ | 2·8 (2·4 to 3·1) | 2·7 (2·2 to 3·1) | 0·0 (−0·5 to 0·5) | .. | 0·60 | |
| Median sequential organ failure assessment score at day 28¶ | 7 (3 to 10) | 6 (4 to 10) | 1 (−3 to 2) | .. | 0·65 | |
| Median clinical ordinal score at 28 days‖ | 3 (1·0 to 4·0) | 3 (1·0 to 5·0) | 0 (−1·0 to 0·0) | .. | 0·47 | |
| Median clinical ordinal score at 90 days** | 1 (1·0 to 1·0) | 1 (1·0 to 1·0) | 0·0 (0·0 to 0·0) | .. | 0·56 | |
| Death at day 90 | 28 (41%) | 31 (40%) | .. | 1·01 (0·52 to 1·97) | 0·97 | |
| Median time to ICU discharge in days** | 21 (15·0 to 27·0) | 21 (13·0 to 29·0) | 1·0 (−6·0 to 7·0) | .. | 0·74 | |
| Median time to hospital discharge in days** | 34 (29·0 to 46·0) | 39 (27·0 to 49·0) | −2·0 (−11·0 to 8·0) | .. | 0·84 | |
Data are n (%), mean (95% CI), or median (IQR). ICU=intensive care unit. IVIG=intravenous immunoglobulins. Adjusted ORs for age, sex, body-mass index.
If not specified data are Hodges-Lehmann median difference.
Clustered Wilcoxon rank sum test using Rosner-Glynn-Lee method stratified according to the centre and invasive mechanical ventilation duration at randomisation day.
Only in survivors extubated within day 28.
When values were missing for one of the 4 components of the lung injury score, it was considered to be 0 and the mean was realised.
When values were missing for one organ of the sequential organ failure assessment score, the organ was considered free of failure.
Only in survivors at day 28.
Only in survivors at day 90.