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. 2023 Jan 7;130:94–100. doi: 10.1016/j.ijid.2022.12.035

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.

a

Farrington and Manning method used to calculate the 95% exact CI for the proportion difference between regdanvimab and SoC cohort in each group

b

P-values were derived from Fisher exact test

c

P-value calculated as a treatment effect from logistic model.

CI, confidence interval; SoC, standard of care.