Table 5.
Regression Model | Covariate | Comparison | Placebo (n = 478) | mAb-Treated (n = 1353) | ||
---|---|---|---|---|---|---|
Risk Ratio (95% CI) | P Value | Risk Ratio (95% CI) | P Value | |||
Unadjusted model 1 | Day 0 AN RNA | 2 log10 copies/mL vs <LLoQ | 2.29 (0.20–26.51) | .51 | 1.03 (0.11–9.95) | .98 |
Per 1 log10 copies/mL above LLoQ higher | 1.35 (0.96–1.91) | .0840 | 1.39 (1.09–1.76) | .0071 | ||
Unadjusted model 2 | Day 3 AN RNA | 2 log10 copies/mL vs <LLoQ | 0.54 (0.12–2.37) | .41 | 2.17 (0.58–8.15) | .25 |
Per 1 log10 copies/mL above LLoQ higher | 1.59 (1.15–2.19) | .0047 | 1.17 (0.81–1.67) | .40 | ||
Mutually adjusted model | Day 0 AN RNA | 2 log10 copies/mL vs <LLoQ | 4.06 (0.29–56.66) | .30 | 0.98 (0.09–10.35) | .99 |
Per 1 log10 copies/mL above LLoQ higher | 1.28 (0.82–1.98) | .28 | 1.33 (1.01–1.76) | .0456 | ||
Day 3 AN RNA | 2 log10 copies/mL vs <LLoQ | 0.22 (0.03–1.58) | .13 | 1.29 (0.33–5.15) | .71 | |
Per 1 log10 copies/mL above LLoQ higher | 1.42 (1.00–2.03) | .0526 | 1.02 (0.68–1.56) | .91 |
“<LLoQ” represents results below the lower limit of quantification (2 log10 copies/mL). Event outcome was hospitalization or death between days 4 and 28. Analyses were restricted to participants with no event before or on day 3.
Unadjusted models 1 and 2 include covariates corresponding to day 0 AN RNA only and day 3 AN RNA only, respectively. The mutually adjusted model includes covariates corresponding to both day 0 and day 3 AN RNA. Separate models were fit for each arm (mAb-treated and placebo). For the day 3 AN RNA only model involving placebo recipients, the 95% CIs and 2-sided Wald test P values are from Poisson regression due to convergence issues with log-binomial regression. All other 95% CIs and 2-sided Wald test P values are from log-binomial regression. Risk ratios with 95% CIs that do not include 1 are bolded.
Abbreviations: AN, anterior nasal; CI, confidence interval; LLoQ, lower limit of quantification; mAb, monoclonal antibody.