Table 1 Average change from baseline (AUC) of COVID-19-related illness as measured by FLU-PRO Plus (total and domain scores) for overall population
Overall population | ||
|---|---|---|
Placebo (N = 529) | Sotrovimab (500 mg IV) (N = 528) | |
Total | ||
AUC to Day 7 | ||
n | 399 | 412 |
Mean (95% CI) | − 1.98 (− 2.20 to − 1.76) | − 3.05 (− 3.27 to − 2.83) |
Difference (95% CI) | − 1.07 (− 1.38 to − 0.76) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 373 | 385 |
Mean (95% CI) | − 7.04 (− 7.51 to − 6.58) | − 9.40 (− 9.85 to − 8.94) |
Difference (95% CI) | − 2.35 (− 3.00 to − 1.70) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 345 | 379 |
Mean (95% CI) | − 13.34 (− 14.03 to − 12.64) | − 16.42 (− 17.09 to − 15.76) |
Difference (95% CI) | − 3.09 (− 4.05 to − 2.12) | |
p value | < 0.001 | |
Nose | ||
AUC to Day 7 | ||
n | 401 | 412 |
Mean (95% CI) | − 2.20 (− 2.49 to − 1.91) | − 3.06 (− 3.34 to − 2.77) |
Difference (95% CI) | − 0.86 (− 1.26 to − 0.45) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 375 | 385 |
Mean (95% CI) | − 7.90 (− 8.48 to − 7.33) | − 9.68 (− 10.25 to − 9.11) |
Difference (95% CI) | − 1.78 (− 2.59 to − 0.97) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 347 | 379 |
Mean (95% CI) | − 14.73 (− 15.58 to − 13.87) | − 16.95 (− 17.77 to − 16.13) |
Difference (95% CI) | − 2.22 (− 3.41 to − 1.04) | |
p value | < 0.001 | |
Throat | ||
AUC to Day 7 | ||
n | 401 | 412 |
Mean (95% CI) | − 2.16 (− 2.44 to − 1.87) | − 3.03 (− 3.31 to − 2.75) |
Difference (95% CI) | − 0.88 (− 1.28 to − 0.48) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 375 | 385 |
Mean (95% CI) | − 6.99 (− 7.54 to − 6.44) | − 8.97 (− 9.51 to − 8.42) |
Difference (95% CI) | − 1.98 (− 2.75 to − 1.21) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 347 | 379 |
Mean (95% CI) | − 12.78 (− 13.58 to − 11.98) | − 15.35 (− 16.11 to − 14.58) |
Difference (95% CI) | − 2.57 (− 3.68 to − 1.46) | |
p value | < 0.001 | |
Eyes | ||
AUC to Day 7 | ||
n | 401 | 412 |
Mean (95% CI) | − 1.54 (− 1.81 to − 1.27) | − 2.33 (− 2.59 to − 2.06) |
Difference (95% CI) | − 0.79 (− 1.17 to − 0.41) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 375 | 385 |
Mean (95% CI) | − 5.29 (− 5.82 to − 4.76) | − 7.03 (− 7.56 to− 6.51) |
Difference (95% CI) | − 1.74 (− 2.49 to − 0.99) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 347 | 379 |
Mean (95% CI) | − 9.76 (− 10.56 to − 8.95) | − 12.07 (− 12.83 to − 11.30) |
Difference (95% CI) | − 2.31 (− 3.42 to − 1.20) | |
p value | < 0.001 | |
Chest/respiratory | ||
AUC to Day 7 | ||
n | 401 | 412 |
Mean (95% CI) | − 1.30 (− 1.56 to − 1.04) | − 2.60 (− 2.86 to − 2.35) |
Difference (95% CI) | − 1.30 (− 1.66 to − 0.93) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 375 | 385 |
Mean (95% CI) | − 5.45 (− 6.02 to − 4.88) | − 8.42 (–8.98 to − 7.85) |
Difference (95% CI) | − 2.97 (− 3.77 to − 2.17) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 347 | 379 |
Mean (95% CI) | − 11.05 (− 11.91 to − 10.19) | − 15.27 (− 16.09 to − 14.44) |
Difference (95% CI) | − 4.22 (− 5.41 to − 3.02) | |
p value | < 0.001 | |
Gastrointestinal | ||
AUC to Day 7 | ||
n | 399 | 412 |
Mean (95% CI) | − 1.47 (− 1.69 to − 1.25) | − 2.15 (− 2.36 to − 1.93) |
Difference (95% CI) | − 0.68 (− 0.98 to − 0.37) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 373 | 385 |
Mean (95% CI) | − 4.88 (− 5.30 to − 4.47) | − 6.55 (− 6.95 to − 6.15) |
Difference (95% CI) | − 1.66 (− 2.24 to − 1.09) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 345 | 379 |
Mean (95% CI) | − 9.17 (− 9.76 to − 8.58) | − 11.03 (− 11.59 to − 10.47) |
Difference (95% CI) | − 1.86 (− 2.67 to − 1.05) | |
p value | < 0.001 | |
Body/systemic | ||
AUC to Day 7 | ||
n | 400 | 412 |
Mean (95% CI) | − 2.55 (− 2.83 to − 2.27) | − 3.88 (− 4.16 to − 3.60) |
Difference (95% CI) | − 1.33 (− 1.73 to − 0.93) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 374 | 385 |
Mean (95% CI) | − 8.98 (− 9.55 to − 8.41) | − 11.75 (− 12.31 to − 11.18) |
Difference (95% CI) | − 2.76 (− 3.57 to − 1.96) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 346 | 379 |
Mean (95% CI) | − 16.87 (− 17.71 to − 16.03) | − 20.45 (− 21.26 to − 19.65) |
Difference (95% CI) | − 3.59 (− 4.75 to − 2.42) | |
p value | < 0.001 | |
Sense | ||
AUC to Day 7 | ||
n | 399 | 412 |
Mean (95% CI) | − 0.10 (− 0.28 to − 0.07) | − 0.55 (− 0.73 to − 0.38) |
Difference (95% CI) | − 0.45 (− 0.70 to − 0.21) | |
p value | < 0.001 | |
AUC to Day 14 | ||
n | 373 | 385 |
Mean (95% CI) | − 1.20 (− 1.60 to − 0.79) | − 2.39 (− 2.79 to − 1.99) |
Difference (95% CI) | −1.19 (−1.76 to −0.62) | |
p value | < 0.001 | |
AUC to Day 21 | ||
n | 345 | 379 |
Mean (95% CI) | − 3.32 (− 3.95 to − 2.68) | − 4.85 (− 5.46 to − 4.24) |
Difference (95% CI) | − 1.53 (− 2.41 to − 0.65) | |
p value | < 0.001 | |