Table 3.
Association Between Day 0 Severe Acute Respiratory Syndrome Coronavirus 2 RNA Results and Subsequent Hospitalization/Death Through Day 28
| Covariate and Comparison | Placebo | mAb-Treated | ||||||
|---|---|---|---|---|---|---|---|---|
| No. | Event Frequency (%) | Risk Ratio (95% CI) | P Value | No. | Event Frequency (%) | Risk Ratio (95% CI) | P Value | |
| Day 0 anterior nasal RNA | 524 | 1491 | ||||||
| <LLoQ | 4/147 (2.7%) | Ref | 4/270 (1.5%) | Ref | ||||
| 2–3.99 log10 copies/mL | 8/110 (7.3%) | 2.67 (0.83–8.65) | .10 | 9/291 (3.1%) | 2.09 (0.65–6.70) | .22 | ||
| 4–5.99 log10 copies/mL | 12/134 (9.0%) | 3.29 (1.09–9.96) | .0350 | 16/416 (3.8%) | 2.60 (0.88–7.68) | .0848 | ||
| ≥6 log10 copies/mL | 21/133 (15.8%) | 5.80 (2.04–16.47) | <.001 | 20/514 (3.9%) | 2.63 (0.91–7.61) | .0751 | ||
| Per 1 log10 copies/mL above LLoQ higher | … | 1.24 (1.04–1.49) | .0167 | … | 0.97 (0.84–1.13) | .72 | ||
| Day 0 blood plasma RNA | 468 | 1461 | ||||||
| Not detected | 18/379 (4.7%) | Ref | 18/1073 (1.7%) | Ref | ||||
| Detected, <LLoQ | 14/85 (16.5%) | 3.47 (1.80–6.69) | <.001 | 24/369 (6.5%) | 3.88 (2.13–7.06) | <.001 | ||
| 2–3.99 log10 copies/mL | 3/4 (75.0%) | 15.79 (7.66–32.56) | <.001 | 6/19 (31.6%) | 18.82 (8.42–42.10) | <.001 | ||
“Not detected” represents results <1.4 log10 copies/mL; “Detected, <LLoQ” represents results 1.4–1.99 log10 copies/mL.
Event outcome was hospitalization or death through day 28. For the quantitative day 0 plasma RNA 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.
Abbreviations: CI, confidence interval; LLoQ, lower limit of quantification; mAb, monoclonal antibody.