Table 2.
Clinical outcomes in patients who received INM005 as compared with placebo.
| Outcomes | INM005 (N = 118) | Placebo (N = 123) | Risk difference or Hazard Ratio (95% CI) | p-value |
|---|---|---|---|---|
| Primary outcome | ||||
| Improvement in at least two categories in WHO ordinal clinical scale at day 28 or discharge | 106 (89•8%) | 104 (84•5%) | Risk difference, 5•28% (−3•95 to 14•50) | 0•15 |
| Secondary outcomes | ||||
| Time to achieve improvement in at least two categories on the ordinal clinical scale (days) | 14•2 ± 7 | 16•3 ± 0•7 | 1•31 (1•00 to 1•74) | 0•05 |
| Improvement in at least two categories in WHO ordinal clinical scale at day 28* (%) | 87•3 ± 3•1 | 79•7 ± 3•6 | •• | 0•08 |
| Improvement in at least two categories in WHO ordinal clinical scale or discharge at day 7* (%) | 64•1 ± 4•4 | 58•3 ± 4•5 | •• | 0•26 |
| Improvement in at least two categories in WHO ordinal clinical scale or discharge at day 14 *(%) | 87•3 ± 3•1 | 79•7 ± 3•6 | •• | 0•05 |
| Time until discharge (days) | 8•7 ± 0•6 | 10•2 ± 0•7 | 1•26 (0•96 to 1•66) | 0•09 |
| Improvement in the ordinal scale for clinical status scale (AUC)⁎⁎ | 60•5 ± 41•7 | 73•7 ± 49•4 | -13•14 (-1•56 to -24•72) | 0•02 |
| Mean category at day 7⁎⁎⁎ | 3•1 ± 1•7 | 2•7 ± 1•7 | 0•63 (0•36 to 1•13) | 0•19 |
| Mean category at day 14⁎⁎⁎ | 2•4 ± 2•2 | 1•7 ± 1•8 | 0•52 (0•29 to 0•96) | 0•03 |
| Mean category at day 21⁎⁎⁎ | 2•1 ± 2•3 | 1•5 ± 1•9 | 0•54 (0•30 to 0•99) | 0•05 |
| Mean category at day 28⁎⁎⁎ | 1•9 ± 2•5 | 1•4 ± 2•1 | 0•80 (0•44 to 1•46) | 0•99 |
| Time until discharge from ICU (days) | 24•7 ± 0•8 | 23•6 ± 0•8 | 0•67 (0•35 to 1•28) | 0•22 |
| Patients requiring ICU admission at day 28* (%) | 12•7 ± 3•1 | 17•8 ± 3•5 | •• | 0•11 |
| Patients requiring invasive mechanical ventilation at day 28* (%) | 9•3 ± 2•6 | 13•9 ± 2•9 | •• | 0•20 |
| Overall mortality* (%) | 6•9 ± 2•3 | 11•4 ± 2•9 | •• | 0•19 |
| Risk to disease progression⁎⁎⁎ | 17 (14•4%) | 29 (23•5%) | 0•54 (0•28 to 1•05) | 0•07 |
⁎
The rates of events in the INM005 and placebo groups were obtained from the Kaplan-Meier survival curves. Therefore, risk ratios cannot be calculated. ** Mean ± standard deviations of the 0-to-28-day Area Under the Curve are provided. The between group difference and its 95% confidence interval is also provided.
⁎⁎⁎
Mean ± standard deviations at each time period. Proportional odds ratio, as calculated by an ordinal logistic regression model are provided. Confidence intervals and p-values were adjusted for multiple comparisons.