Table 2.
Proportion of patients who deteriorated to peripheral oxygen saturation <90% in room air, required supplemental oxygen therapy above high flow, or experienced mortality due to COVID-19 up to Day 28 (primary efficacy endpoint) and logistic regression model with treatment as a fixed effect and age, body mass index, at least one high-risk factor and at least one COVID-19 vaccine as covariates
Primary efficacy endpoint | Logistic regression model | |||
---|---|---|---|---|
Regdanvimab | SoC | % difference (95% CI) [P-value]a,b | Odds ratio (95% CI) [P-value]c | |
Overall study cohort | 13/418 (3.1) | 30/304 (9.9) | -6.8 (-10.9, -2.8) [0.0002] | 0.4241 (0.2108, 0.8532) [0.0162] |
Delta variant subgroup | 8/297 (2.7) | 8/115 (7.0) | -4.3 (-10.8, 0.2) [0.0827] | 0.3395 (0.1168, 0.9873) [0.0473] |
Data are n (%), unless otherwise specified.
Farrington and Manning method used to calculate the 95% exact CI for the proportion difference between regdanvimab and SoC cohort in each group
P-values were derived from Fisher exact test
P-value calculated as a treatment effect from logistic model.
CI, confidence interval; SoC, standard of care.