Table 2.
Mean SARS-CoV-2 viral load (log10 copies per mL) change from baseline through day 8 in adult COVID-19 infected patients (mITT high risk population: MMRM).
| Parameter | Statistics | NONS (N =64) | PLACEBO N =69) |
|---|---|---|---|
| Baseline (Day 1) | mean (SD) | 6·96 (1·506) | 7·16 (1·532) |
| median | 6·79 | 7·30 | |
| minimum, maximum | 2·56, 10·10 | 2·58, 10·81 | |
| Mean CFB through Day 3 | LSM (SE) | -1·57 (0·199) | -0·74 (0·193) |
| 95% CI | -1·96, -1·17 | -1·13, -0·36 | |
| Difference: LSM (SE) | -0·82 (0·277) | ||
| 95% CI of difference | -1·37, -0·27 | ||
| p-value of difference | 0·003 | ||
| Mean CFB through Day 4 | LSM (SE) | -2·15 (0·171) | -1·48 (0·167) |
| 95% CI | -2·49, -1·82 | -1·80, -1·15 | |
| Difference: LSM (SE) | -0·68 (0·240) | ||
| 95% CI of difference | -1·15, -0·21 | ||
| p-value of difference | 0·005 | ||
| Mean CFB through Day 8 | LSM (SE) | -2·62 (0·145) | -2·10 (0·141) |
| 95% CI | -2·91, -2·34 | -2·38, -1·83 | |
| Difference: LSM (SE) | -0·52 (0·202) | ||
| 95% CI of difference | -0·92, -0·12 | ||
| p-value of difference | 0·010 |
CFB = Change from baseline.
Mean change from baseline in viral load log values through Day eight (7 days of therapy) was analysed by MMRM. The difference LSM(SE) between groups was calculated for NONS vs placebo (NONS-placebo). Patients were required to have a positive RT-PCR at Day one (screening) and Day two (≤ 24 post randomisation). The 95% confidence interval (CI) for the LSM mean difference between groups was calculated for NONS minus placebo. p-values were calculated for the comparison of treatment groups with treatment as main effect and by considering visit, baseline value, risk factor (high risk yes/no), and treatment by visit interaction as covariates.