TABLE 3.
Disease severity endpoints (ITT-I analysis set)
| Parameterd | Treatment group |
||
|---|---|---|---|
| RV521 350 mg (N = 16) | RV521 200 mg (N = 18) | Placebo (N = 19) | |
| AUC total symptom score (score × hours) | |||
| Mean (SE) | 82.41 (24.45) | 111.35 (33.88) | 381.82 (111.59) |
| Reduction in mean relative to that of placebo (%) | 78.42 | 70.84 | |
| P valuea | 0.002 | 0.009 | |
| Peak total symptom score | |||
| Mean (SE) | 1.9 (0.45) | 2.3 (0.48) | 5.1 (1.11) |
| Difference in mean relative to that of placebo (95% CI) | −3.12 (−5.59, −0.64) | −2.72 (−5.22, −0.22) | |
| P valueb | 0.016 | 0.034 | |
| Time to peak total symptom score (days) | |||
| Mean (SE) | 1.56 (0.57) | 2.08 (0.68) | 1.83 (0.23) |
| Difference in mean relative to that of placebo (95% CI) | −0.26 (−1.56, 1.03) | 0.25 (−1.24, 1.75) | |
| P valueb | 0.675 | 0.731 | |
| Daily nasal mucus weight (g) | |||
| LS meanc | 0.27 | 0.33 | 0.61 |
| Difference in LS mean relative to that of placebo (%) | 55.74 | 45.90 | |
| P valuea | 0.010 | 0.038 | |
a
Wilcoxon rank-sum test.
b
Satterthwaite t test.
c
LS mean was calculated from a mixed model with repeated measures, adjusted for baseline mucus weight and treatment group as covariates and subject as a random effect. The P value represents the LS mean difference between treatment groups.
d
AUC, area under the curve; CI, confidence interval; ITT-I, intent-to-treat infected (defined as all randomized subjects who received the challenge virus and at least one dose of study drug and met the criterion for laboratory-confirmed RSV infection [presence of viral shedding]); LS, least squares; RSV, respiratory syncytial virus; SE, standard error.