Table 2. Primary, secondary, and exploratory study outcomes.
| Parallel SOC (N = 130) | SOC + Anakinra after propensity matching (N = 130) | OR (95% CI) | p-value | |
|---|---|---|---|---|
| Severe respiratory failure by day 14, No. (%) | 77 (59.2) | 29 (22.3) | 0.19 (0.12–0.34) | <0.0001 |
| Mechanical ventilation (MV) by day 14, No. (%) | 65 (50.0) | 25 (19.2) | 0.24 (0.14–0.42) | <0.0001 |
| Non-invasive MV by day 14, No. (%) | 9 (6.9) | 6 (4.6) | 0.65 (0.23–1.88) | 0.596 |
| 14-day mortality, No. (%) | 16 (12.3) | 6 (4.6) | 0.35 (0.13–0.91) | 0.043 |
| SOFA score on day 7, median (Q1–Q3) | 2 (0 to 3) | 1 (0 to 3) | NA | 0.540 |
| SOFA score on day 14, median (Q1–Q3) | 2 (0–9) | 1 (0–3) | NA | 0.191 |
| Absolute change of SOFA score by day 7 compared to baseline, median (Q1–Q3) | 0 (−1 to 1) | 0 (−1 to 0) | NA | 0.356 |
| Absolute change of SOFA score by day 14 compared to baseline, median (Q1–Q3) | 0 (−1 to 6) | −2 (−1 to 0) | NA | 0.004 |
| Absolute change of respiratory symptoms score by day 7 compared to baseline, median (Q1–Q3) | 0 (0 to 0.75) | −1 (−3 to 0) | NA | 0.019 |
| Absolute change of respiratory symptoms score by day 14 compared to baseline, median (Q1–Q3) | 0 (−0.75 to 0) | −2 (−4 to −1) | NA | 0.016 |
| Ventilator-free days, mean (SD) | 18 (11) | 25 (8) | NA | <0.0001 |
| 30-day mortality, No. (%) | 29 (22.3) | 15 (11.5) | 0.45 (0.23–0.90) | 0.031 |
| 90-day mortality, No. (%) | 40 (30.8) | 22 (16.9) | 0.46 (0.25–0.83) | 0.013 |
Abbreviations: CI: confidence interval; n: number; NA: non-applicable; OR: odds ratio; Q: quartile; SD: standard deviation; SOC; standard-of-care; SOFA: sequential organ failure assessment.