Table 2.
Analysis of Time to Event Endpoints, ITT Population.
| Favipiravir | Control | |
|---|---|---|
| Time to Cessation of SARS-CoV-2 Oral Shedding (Primary Endpoint) | ||
| No. of patients | N = 72 | N = 75 |
| No. of events (%) | 70 (97.2) | 68 (90.7) |
| Time to event, median days (95%CI) | 5.0 (4.0, 7.0) | 7.0 (5.0, 8.0) |
| Log-rank P value | 0.1290 | |
| Hazard Ratio (95% CI) | 1.367 (0.944, 1.979) | |
| Hazard Ratio P value | 0.098 | |
| Time to Clinical Cure | ||
| No. of patientsa | N = 53 | N = 49 |
| No. of events (%) | 51 (96.2) | 46 (93.9) |
| Time to event, median days (95% CI) | 3.0 (3.0, 4.0) | 5.0 (4.0, 6.0) |
| Log-rank P value | 0.0297 | |
| Hazard Ratio (95% CI) | 1.749 (1.096, 2.792) | |
| Hazard Ratio P value | 0.019 | |
| Time to First Use of High-Flow Supplemental Oxygen, Ventilation (Non-Invasive or Mechanical), or Extracorporeal Membrane Oxygenation | ||
| No. of patientsb | N = 7 | N = 7 |
| No. of events (%) | 7 (100) | 7 (100) |
| Time to event, median days (95% CI) | 5.0 (1.0, 6.0) | 2.0 (1.0, 4.0) |
| Log-rank P value | 0.0653 | |
| Hazard Ratio (95% CI) | 0.065 (0.005, 0.809) | |
| Hazard Ratio P value | 0.034 | |
| Time to Hospital Discharge | ||
| No. of patients | N = 72 | N = 75 |
| No. of events (%) | 70 (97.2) | 68 (90.7) |
| Time to event, median days (95% CI) | 9.0 (7.0, 10.0) | 10.0 (8.0, 12.0) |
| Log-rank P value | 0.1079 | |
| Hazard Ratio (95% CI) | 1.406 (0.974, 2.030) | |
| Hazard Ratio P value | 0.069 | |
ITT, intent-to-treat.
The ITT population excluded 2 subjects with no drug intake (favipiravir arm) and 1 subject with no post baseline efficacy assessment (favipiravir arm).
The favipiravir arm received treatment with favipiravir + standard supportive care; the control arm received standard supportive care alone.
Kaplan–Meier was used to estimate the median duration of time-to-event and 95% confidence intervals. The two treatment groups were compared using a log-rank test to estimate the P value. The hazard ratio of favipiravir/control and the corresponding P value were computed based on the Cox regression model with covariates of age, treatment, and baseline comorbidity. Subjects who terminated the study without the documented event were censored at day 28. Subjects who died without documented event were censored at day 28 or the date of death, whichever was later.
Only patients with clinical signs and symptoms at baseline were included in this analysis.
Because most of the subjects did not require oxygen support, the censoring rate is too high to run the Kaplan–Meier analysis to estimate the median time-to-event; therefore, only results from noncensored data were presented for this endpoint.