Table 2.
Efficacy and safety outcomes.
| Treatment arm | Measure of association | |||
|---|---|---|---|---|
| Lambda (n = 60) | Placebo (n = 60) | aHR (95% CI) | p-value | |
| Primary efficacy outcome | ||||
| Duration until viral shedding cessation in days, median (95% CI) | 7 (5–13) | 7 (5–10) | 0.81 (0.56, 1.19) | 0.29 |
| Secondary efficacy outcomes | ||||
| Duration until resolution of symptoms in days, median (95% CI) | 8 (6–11) | 9 (5–11) | 0.94 (0.64, 1.39) | 0.76 |
| Hospitalizations by Day 28, n participants (%) | 2 (3.3%) | 2 (3.3%) | – | 1 |
| Emergency Department visits by Day 28, n participants (%) | 5 (8.3%) | 3 (5%) | – | 0.71 |
| ∆ Log change (95% CI) | p-value | |||
| Log Oropharyngeal viral load over time, mean change at day 14 (SD) | −4.3 (4.3) | −4.9 (4.7) | −0.06 (−1.23, 1.11) | 0.91 |
| ∆ AUC (95% CI) | p-value | |||
| Log10 viral load area under the curve through day 14, median (IQR) | 28.5 (20.1) | 29.6 (19.0) | 1.01 (0.85, 1.16) | 0.95 |
| Exploratory efficacy outcomes | aHR (95% CI) | p-value | ||
| Duration until sustained symptom resolution in days, median (95% CI) | 20 (16–27) | 20 (17–24) | 0.92 (0.60, 1.41) | 0.70 |
| Duration until respiratory symptom resolution in days, median (95% CI) | 6 (4–7) | 4 (2–7) | 0.99 (0.64, 1.53) | 0.95 |
| Duration until systemic and respiratory symptom resolution in days, median (95% CI) | 8 (6–11) | 5.5 (5–10) | 0.93 (0.63, 1.38) | 0.73 |
| Duration until disease progression in days, median among those who progress* (IQR) | 5 (1) | 2 (1) | 1.38 (0.52, 3.63) | 0.52 |
| Safety outcomes | ||||
| Serious adverse events, n (%) | 2 (3.3%) | 2 (3.3%) | – | 1 |
| Number of adverse events, n | 36 | 30 | – | |
| Participants with adverse events, n (%) | 25 (41.7%) | 21 (35.0%) | – | 0.57 |
| LFT-related adverse events, n | 16 | 5 | – | |
| Participants with LFT-related adverse events, n (%) | 15 (25.0%) | 5 (8.3%) | – | 0.027 |
Source data available at https://purl.stanford.edu/hc972ys6733.
IQR inner quartile range; aHR adjusted hazard ratio (adjusted for age 50+ and sex), aHR > 1 favors faster shedding cessation in Lambda vs. placebo arms; aHR <1 favors delayed shedding cessation in Lambda vs. placebo arms, AUC area under the curve.
aNumber of participants that progressed—10 in Lambda, 7 in placebo.