Table 4.
Mean change from baseline over time in SARS-CoV-2 RNA titer (log10 copies/mL) from nasopharyngeal samples, determined using the quantitative assay, in the modified intention-to-treat population, by subgroup
| Visit | Molnupiravir | Placebo | ||||
|---|---|---|---|---|---|---|
| n | Meana | Mean changea (SD) | n | Meana | Mean changea (SD) | |
| All MITT participants | ||||||
| Baseline | 614 | 6.89 | N/A | 597 | 6.91 | N/A |
| Day 3b | 570 | 5.75 | − 1.17 (1.450) | 570 | 5.96 | − 0.97 (1.352) |
| EOT (day 5)b | 558 | 4.68 | − 2.25 (1.633) | 547 | 4.96 | − 1.95 (1.580) |
| Day 10b | 518 | 3.59 | − 3.30 (1.737) | 510 | 3.75 | − 3.16 (1.773) |
| Day 15 | 515 | 3.14 | − 3.73 (1.880) | 506 | 3.22 | − 3.69 (1.913) |
| Day 29 | 516 | 2.84 | − 4.00 (1.814) | 513 | 2.85 | − 4.08 (1.843) |
| MITT participants with baseline SARS-CoV-2 RNA titer ≤106 copies/mL | ||||||
| Baseline | 182 | 4.62 | N/A | 180 | 4.62 | N/A |
| Day 3b | 167 | 3.98 | − 0.63 (1.377) | 170 | 4.25 | − 0.36 (1.241) |
| EOT (day 5) | 162 | 3.53 | − 1.08 (1.223) | 166 | 3.65 | − 0.96 (1.357) |
| Day 10 | 152 | 3.02 | − 1.58 (1.000) | 157 | 3.13 | − 1.46 (1.251) |
| Day 15 | 154 | 2.99 | − 1.63 (1.154) | 156 | 3.08 | − 1.55 (1.222) |
| Day 29 | 153 | 2.78 | − 1.76 (0.946) | 154 | 2.77 | − 1.83 (0.967) |
| MITT participants with baseline SARS-CoV-2 RNA titer > 106 copies/mL | ||||||
| Baseline | 432 | 7.84 | N/A | 417 | 7.90 | N/A |
| Day 3 | 403 | 6.49 | − 1.39 (1.422) | 400 | 6.69 | − 1.23 (1.314) |
| EOT (day 5)b | 396 | 5.15 | − 2.73 (1.534) | 381 | 5.53 | − 2.39 (1.474) |
| Day 10 | 366 | 3.83 | − 4.02 (1.452) | 353 | 4.02 | − 3.92 (1.409) |
| Day 15 | 361 | 3.21 | − 4.63 (1.335) | 350 | 3.28 | − 4.64 (1.292) |
| Day 29 | 363 | 2.87 | − 4.95 (1.136) | 359 | 2.88 | − 5.04 (1.168) |
| MITT participants with clade 20J (Gamma) | ||||||
| Baseline | 35 | 7.86 | N/A | 50 | 7.73 | N/A |
| Day 3 | 33 | 7.35 | − 0.63 (1.147) | 48 | 6.76 | − 1.01 (1.183) |
| EOT (day 5) | 32 | 5.47 | − 2.47 (1.543) | 48 | 5.73 | − 2.05 (1.508) |
| Day 10 | 33 | 4.10 | − 3.79 (1.664) | 42 | 4.15 | − 3.73 (1.492) |
| Day 15 | 31 | 3.62 | − 4.28 (1.699) | 42 | 3.76 | − 3.85 (1.432) |
| Day 29 | 29 | 2.89 | − 4.96 (1.279) | 43 | 3.09 | − 4.66 (1.613) |
| MITT participants with clade 21H (Mu) | ||||||
| Baseline | 82 | 7.13 | N/A | 91 | 7.29 | N/A |
| Day 3b | 80 | 5.87 | − 1.28 (1.433) | 87 | 6.46 | − 0.87 (1.524) |
| EOT (day 5) | 78 | 5.07 | − 2.11 (1.511) | 83 | 5.38 | − 1.94 (1.684) |
| Day 10 | 70 | 4.18 | − 3.13 (1.642) | 79 | 4.24 | − 3.14 (1.680) |
| Day 15 | 74 | 3.44 | − 3.67 (1.960) | 74 | 3.55 | − 3.81 (1.844) |
| Day 29 | 68 | 3.03 | − 4.09 (1.640) | 72 | 3.00 | − 4.32 (1.576) |
| MITT participants with clade 21I (Delta) | ||||||
| Baseline | 54 | 7.42 | N/A | 44 | 7.49 | N/A |
| Day 3 | 53 | 6.03 | − 1.33 (1.397) | 42 | 6.62 | − 0.89 (1.142) |
| EOT (day 5)b | 50 | 4.90 | − 2.53 (1.307) | 42 | 5.52 | − 2.06 (1.543) |
| Day 10 | 51 | 3.56 | − 3.81 (1.531) | 39 | 3.89 | − 3.58 (1.589) |
| Day 15 | 49 | 3.07 | − 4.25 (1.746) | 35 | 2.92 | − 4.65 (1.544) |
| Day 29 | 49 | 2.85 | − 4.58 (1.648) | 40 | 2.73 | − 4.69 (1.553) |
| MITT participants with clade 21J (Delta) | ||||||
| Baseline | 239 | 7.16 | N/A | 290 | 7.13 | N/A |
| Day 3 | 268 | 5.91 | − 1.28 (1.530) | 276 | 6.03 | − 1.14 (1.382) |
| EOT (day 5)b | 270 | 4.71 | − 2.45 (1.620) | 262 | 5.06 | − 2.11 (1.533) |
| Day 10b | 239 | 3.48 | − 3.62 (1.588) | 246 | 3.73 | − 3.44 (1.699) |
| Day 15 | 234 | 3.05 | − 4.09 (1.635) | 249 | 3.17 | − 3.98 (1.722) |
| Day 29 | 239 | 2.78 | − 4.31 (1.490) | 257 | 2.80 | − 4.39 (1.586) |
EOT end of treatment, MITT modified intention-to-treat population, n number of participants with data available at the corresponding time point, N/A not applicable, SD standard deviation
aMean and mean change from baseline are based on the measurements from participants with values at both baseline and the timepoint assessed
b95% confidence interval for difference in geometric least-squares mean values molnupiravir vs. placebo excludes zero