Table 5.
Clinical outcomes in the sensitivity analysis population.
| Median (IQR) | |||||
|---|---|---|---|---|---|
| Outcomes | Sarilumab + SC (n = 20) | SC (n = 7) | Hazard ratio (SE) | Log hazard ratio | P Value |
| (Log SE) | |||||
| Primary outcomes | |||||
| Median change in clinical status (7-category ordinal scalea) at day 7, | 2 (0–3) | 3 (0–3) | - | - | 0.36 |
| Mean change in clinical status at day 7, (SD) | 1.45 (1.93) | 2.14 (1.46) | - | - | 0.40 |
| 30-day mortality, n (%)b | 2 (10) | 0 | - | 15.01 (22.60) | 0.54 |
| Duration of hospitalization, days from randomizationc | 7 (6–11) | 5 (4-12) | 0.54 (0.25) | - | 0.12 |
| Secondary outcomes | |||||
| Median change in clinical status at day 14 | 3 (2-3) | 3 (3) | - | - | 0.45 |
| Time to become afebrile for a minimum of 48 h, daysd | 3 (3-6) | 15 (8-22) | 5.27 (5.70) | - | 0.042 |
| Progression to NIMV, n (%) | 4 (20) | 0 (0) | - | 16.30 (-) | 0.27 |
| Progression to IMV, n (%) | 3 (15) | 0 (0) | - | 15.01 (22.60) | 0.5 |
| Time to supplemental oxygen withdrawal, days from randomization | 6 (4-15) | 3 (2-8) | 0.58 (0.28) | - | 0.091 |
IMV, invasive mechanical ventilation; IQR, interquartile ranges; NIMV, Noninvasive mechanical ventilation; ES, standard deviation; SC, Standard care; SE, Standard error.
a
Scale range: 1 = death to 7 = non hospitalized.
b
One patient in the SC arm was lost to follow-up after discharging alive at day 13.
c
Accounting for survival status by treating patients who died as having a 30-day hospital stay.
d
Only 2 patients in the SC arm and 11 in the SAR+SC arm were febrile at randomization.