Table 2. Primary and Key Secondary Efficacy End Points.*.
| End Point | REGEN-COV (N=753) |
Placebo (N=752) |
|---|---|---|
| Primary end point: symptomatic RT-qPCR–confirmed SARS-CoV-2 infection, broad-term definition† | ||
| No. of participants (%) | 11 (1.5) | 59 (7.8) |
| Relative risk reduction — % | 81.4 | — |
| Odds ratio (95% CI) | 0.17 (0.09–0.33) | — |
| P value‡ | <0.001 | — |
| Viral load >104 copies/ml§ | ||
| No. of participants/total no. (%) | 12/745 (1.6) | 85/749 (11.3) |
| Relative risk reduction — % | 85.8 | — |
| Odds ratio (95% CI) | 0.13 (0.07–0.24) | — |
| P value‡ | <0.001 | — |
| Duration of symptomatic RT-qPCR–confirmed SARS-CoV-2 infection, broad-term definition | ||
| Total no. of wk | 12.9 | 187.7 |
| Total duration/1000 participants — wk | 17.1 | 249.6 |
| Relative difference vs. placebo — %¶ | 93.1 | — |
| P value‖ | <0.001 | — |
| Mean duration of symptoms/participant with symptomatic infection — wk | 1.2±1.0 | 3.2±2.7 |
| Duration of high viral load (>104 copies/ml) among all participants§ | ||
| Total no. of wk | 14.0 | 136.0 |
| Total duration/1000 participants — wk | 18.8 | 181.6 |
| Relative difference vs. placebo — %¶ | 89.6 | — |
| P value‖ | <0.001 | — |
| Mean duration of high viral load/infected participant — wk | 0.4±0.6 | 1.3±0.9 |
| Duration of any RT-qPCR–confirmed symptomatic or asymptomatic SARS-CoV-2 infection | ||
| Total no. of wk | 41.0 | 231.0 |
| Total duration/1000 participants — wk | 54.4 | 307.2 |
| Relative difference vs. placebo — %¶ | 82.3 | — |
| P value‖ | <0.001 | — |
| Mean duration of overall infection/infected participant — wk | 1.1±0.4 | 2.2±1.1 |
| Any RT-qPCR–confirmed symptomatic or asymptomatic SARS-CoV-2 infection | ||
| No. of participants (%) | 36 (4.8) | 107 (14.2) |
| Relative risk reduction — % | 66.4 | — |
| Odds ratio (95% CI) | 0.31 (0.21–0.46) | — |
| P value** | <0.001 | — |
Plus–minus values are means ±SD. Key secondary end points are presented in order of the hierarchical testing sequence. CI denotes confidence interval, RT-qPCR reverse-transcriptase–quantitative polymerase chain reaction, and SARS-CoV-2 severe acute respiratory syndrome coronavirus 2.
A sensitivity analysis with the use of a generalized estimation equation showed similar results.
The P value was based on a logistic-regression model adjusted for region (United States or other country) and age group (12 to 49 years or ≥50 years).
For the viral-load end points, only participants with at least one viral-load assessment during the 28-day efficacy assessment period were included in the analysis.
The calculation of the relative difference between REGEN-COV and placebo was based on the normalized weeks per 1000 participants.
The P value was based on a stratified Wilcoxon rank-sum test (van Elteren test) with region (United States or other country) and age group (12 to 49 years or ≥50 years) as strata.
The P value was based on multiple imputation with the use of fully conditional specification followed by a logistic-regression model including the trial group, region (United States or other country), and age group (12 to 49 years or ≥50 years).