TABLE 1.
Median time to improvement in clinical conditions and the proportion of improvement in clinical conditions on day 7 after the administration of Azvudine and placebo.
| Parameters | Full analysis set | Per protocol set | ||
|---|---|---|---|---|
| Azvudine | Placebo | Azvudine | Placebo | |
| N (missing) | 157 (0) | 157 (0) | 141 (0) | 138 (0) |
| Endpoint (%) | 138 (87.90%) | 136 (86.62%) | 137 (97.16%) | 136 (98.55%) |
| Censoring (%) | 19 (12.10%) | 21 (13.38%) | 4 (2.84%) | 2 (1.45%) |
| Improvement | 57 (36.31%) | 15 (9.55%) | 57 (40.43%) | 15 (10.87%) |
| No improvement | 100 (63.69%) | 142 (90.45%) | 84 (59.57%) | 123 (89.13%) |
| p-value | <0.001 | <0.001 | ||
| Median time | 10.00 | 13.00 | 10.00 | 13.00 |
| p-value | <0.001 | <0.001 | ||
The clinical data were obtained from the package insert of Azvudine tablets manufactured by Henan Sincere Biotechnology Co., Ltd.
The missing values in the primary efficacy outcome were imputed using the worst value method.
Clinical conditions were determined according to the WHO Ordinary Clinical Progression Scale (Jun/2020), score of 4 to 10. The data were acquired according to the WHO score between day 1 and day 31.
The time to improvement in clinical conditions was calculated in terms of the first time improvement in clinical conditions emerged, which was determined by a decrease of ≥ 2 in the WHO score. Patients without any improvement in clinical condition by the end of the study were denoted as censoring patients. The last time that the WHO score was determined was used to calculate the censoring time.