Table 2 Primary and secondary study endpoints
Placebo (n = 189) | Anakinra (n = 405) | OR (95% CI) | P value | |
|---|---|---|---|---|
WHO-CPS by day 28 | 0.36 (0.26–0.50) | <0.0001 | ||
Fully recovered PCR−, n (%) | 50 (26.5) | 204 (50.4) | ||
Asymptomatic PCR+, n (%) | 6 (3.2) | 40 (9.9) | ||
Symptomatic independent, n (%) | 74 (39.2) | 93 (23.0) | ||
Symptomatic assistance needed, n (%) | 21 (11.1) | 25 (6.2) | ||
Hospitalized with no need for oxygen, n (%) | 3 (1.6) | 9 (2.2) | ||
Hospitalized with nasal/mask oxygen, n (%) | 10 (5.3) | 8 (2.0) | ||
Need for HFO or NIV, n (%) | 1 (0.5) | 1 (0.2) | ||
MV with P/F > 150 mmHg, n (%) | 1 (0.5) | 1 (0.2) | ||
MV with P/F < 150 mmHg or vasopressors, n (%) | 4 (2.1) | 5 (1.2) | ||
MV with P/F < 150 mmHg and vasopressors or hemodialysis or ECMO, n (%) | 6 (3.2) | 6 (1.5) | ||
Dead, n (%) | 13 (6.9) | 13 (3.2) | ||
Absolute decrease of WHO-CPS at day 28 from baseline day 1, median (IQR) | 3 (2.5) | 4 (2.0) | 0.40 (0.29–0.55) | <0.0001 |
Absolute decrease of WHO-CPS at day 14 from baseline day 1, median (IQR) | 2 (3.0) | 3 (2.0) | 0.63 (0.46–0.86) | 0.003 |
Absolute decrease of SOFA score at day 7 from baseline day 1, median (IQR) | 0 (1) | 1 (2) | 0.64 (0.47–0.88) | 0.007 |
Median (IQR) time to hospital discharge, d | 12 (8.5) | 11 (7.8) | 1.22 (1.02–1.47)a | 0.033 |
Median (IQR) time of ICU stay, db | 14 (22) | 10 (21) | 2.33 (1.11–4.92)a | 0.026 |
