Table 2.
Efficacy outcomes in ITT population and the results of subgroup analysis
| Measure | Favipiravir | SOC | Hazard ratio/Risk ratio (95% CI) | P-value |
|---|---|---|---|---|
| Primary outcomes and subgroup analysis | ||||
| Time to clinical improvement | ||||
| All patients (N=168) | ||||
| N | 112 | 56 | - | - |
| Median (IQR). days | 6.0 (4.00; 9.25) | 10.0 (5.00; 21.0) | 1.63 (1.14; 2.34) | 0.007§,* |
| Outpatients (N=127) | ||||
| N | 83 | 44 | - | - |
| Median (IQR). days | 6.0 (4.0; 12.0) | 14.0 (5.0; 28.0) | 1.65 (1.08; 2.52) | 0.019§,* |
| Hospitalized patients (N=41) | ||||
| N | 29 | 12 | - | - |
| Median (IQR). days | 7.0 (5.0; 9.0) | 8.5 (6.0; 10.0) | 1.42 (0.72; 2.81) | 0.271§ |
| Time to viral clearance | ||||
| All patients (N=168) | ||||
| N | 112 | 56 | - | - |
| Median (IQR). days | 3.0 (3.0; 3.5) | 3.0 (3.0; 7.0) | 1.28 (0.92; 1.79) | 0.161§ |
| Outpatients (N=127) | ||||
| N | 83 | 44 | - | - |
| Median (IQR). days | 3.0 (3.0; 3.5) | 3.0 (3.0; 7.0) | 1.11 (0.76; 1.61) | 0.459§ |
| Hospitalized patients (N=41) | ||||
| N | 29 | 12 | - | - |
| Median (IQR). days | 3.0 (3.0; 3.0) | 5.0 (4.5; 5.5) | 2.11 (1.04; 4.31) | 0.038§,* |
| Key secondary and exploratory outcomes | ||||
| Rate of clinical improvement | ||||
| N | 112 | 56 | - | - |
| Day 7 | 59 (52.7%) | 20 (35.7%) | 1.50 (1.02; 2.22) | 0.020* |
| Day 14 | 93 (83.0%) | 37 (66.1%) | 1.28 (1.05; 1.56) | 0.005* |
| Day 28 | 96 (85.7%) | 44 (78.6%) | 1.11 (0.96; 1.29) | 0.098 |
| Rate of viral clearance | ||||
| N | 112 | 56 | - | - |
| Day 3 | 80 (71.4%) | 32 (57.1%) | 1.27 (0.99; 1.64) | 0.030* |
| Day 5 | 91 (81.2%) | 38 (67.9%) | 1.22 (1.00; 1.48) | 0.022* |
| Day 7 | 95 (84.8%) | 46 (82.1%) | 1.05 (0.92; 1.21) | 0.296 |
| Day 10 | 101 (90.2%) | 49 (87.5%) | 1.05 (0.95; 1.17) | 0.244 |
| Day 14 | 103 (92.0%) | 53 (94.6%) | 0.99 (0.93; 1.06) | 0.750 |
| Day 21 | 105 (93.8%) | 53 (94.6%) | 1.01 (0.95; 1.07) | 0.549 |
| Day 28 | 105 (93.8%) | 53 (94.6%) | 1.01 (0.95; 1.07) | 0.549 |
| Rate of pneumonia resolution on CT scans | ||||
| All patients (N=168) | ||||
| N | 112 | 56 | - | - |
| Day 5 | 3 (2.7%) | 0 (0.0%) | n.a. | 0.553 |
| Day 14 | 14 (12.5%) | 5 (8.9%) | n.a. | 0.613 |
| Day 28& | 27 (24.1%) | 12 (21.4%) | n.a. | 0.847 |
| Hospitalized patients (N=41) | ||||
| N | 29 | 12 | - | - |
| Day 5 | 0 (0.0%) | 0 (0.0%) | n.a. | - |
| Day 14 | 3 (10.3%) | 1 (8.3%) | n.a. | 1.000 |
| Day 28& | 9 (31.0%) | 1 (8.3%) | n.a. | 0.231 |
| Rate of other disease outcomes | ||||
| N | 112 | 56 | - | - |
| Hospitalization | 3 (3.6%) | 2 (4.5%) | 0.94 (0.78; 1.14) | 0.494 |
| Transfer to ICU | 3 (2.7%) | 1 (1.8%) | 1.51 (0.16; 4.21) | 1.000 |
| Invasive ventilation | 1 (0.9%) | 0 (0.0%) | - | 1.000 |
| Hospitalization | 3 (3.6%) | 2 (4.5%) | 0.94 (0.78; 1.14) | 0.494 |
Data are n (%) unless otherwise stated. Abbreviations: ITT-intent-to-treat population; CI-confidential intervals; SOC-standard of care; n.a.-not applicable; IQR-interquartile range; CT-computed tomography; ICU-intensive care unit.
*
The difference is statistically significant.
§
P-values were calculated using a log rank test.
&
On Day 28, the best response for the study was taken into account, since for a number of patients had resolution on CT at previous visits. CT on the Day 28 was not performed according to the protocol and by the decision of the investigator.