Table 1.
Open in new tab

Time-Weighted Average Change in Viral Load From Baseline in Immunocompromised Patients Compared With the Overall Population

TWA ChangeOverall Study PopulationImmunocompromised Population
Placebo
(n = 633)		CAS + IMD 2.4 g IV (n = 664)CAS + IMD 8.0 g IV (n = 643)CAS + IMD Combined Doses
(n = 1307)		Placebo
(n = 35)		CAS + IMD 2.4 g IV (n = 32)CAS + IMD 8.0 g IV (n = 32)CAS + IMD Combined Doses
(n = 64)
Median baseline VL, log10 copies/mL6.286.356.366.366.897.516.877.36
TWA change from day 1 to day 7
 No.567584572115630302959
 LS mean (SE)−.93 (0.05)−1.27 (.05)−1.21 (.05)−1.24 (.04)−.49 (.29)−1.43 (.28)−.92 (.26)−1.16 (.22)
 95% CI−1.03 to −.83−1.37 to −1.17−1.31 to −1.11−1.32 to −1.16−1.06 to .08−1.99 to −.88−1.44 to −.40−1.59 to −.73
 Difference vs placebo…−.34 (.06)−.28 (.06)−.31 (.06)…−.94 (.32)−.43 (.32)−.69 (.28)
 95% CI…−.47 to −.22−.41 to −.15−.42 to −.20…−1.58 to −.31−1.07 to .20−1.25 to −.14
 P Value…<.0001<.0001<.0001….0041.1801.0146
TWA change from day 1 to day 13
 LS mean (SE)−1.51 (.06)−1.95 (.06)−1.94 (.06)−1.95 (.05)−1.17 (.38)−2.52 (.38)−1.75 (.35)−2.09 (.29)
 95% CI−1.63 to −1.39−2.07 to −1.84−2.06 to −1.82−2.04 to −1.86−1.92 to −.41−3.27 to −1.77−2.45 to −1.06−2.67 to −1.50
 Difference vs placebo…−.45 (.08)−.44 (.08)−.44 (.07)…−1.35 (.42)−.59 (.42)−.96 (.37)
 95% CI…−.60 to −.30−.59 to −.29−.57 to −.31…−2.19 to −.51−1.43 to .26−1.69 to −.23
 P Value…<.0001<.0001<.0001….0021.1699.0107
TWA change from day 1 to day 29
 LS mean (SE)−2.46 (.08)−2.90 (.07)−2.96 (.08)−2.93 (.06)−2.08 (.44)−3.70 (.46)−3.50 (.43)−3.60 (.35)
 95% CI−2.61 to −2.31−3.05 to −2.75−3.11 to −2.82−3.05 to −2.82−2.95 to −1.21−4.62 to −2.79−4.36 to −2.64−4.30 to −2.91
 Difference vs placebo…−.44 (.09)−.50 (.09)−.47 (.08)…−1.62 (.52)−1.42 (.52)−1.53 (.44)
 95% CI…−.62 to −.25−.69 to −.32−.63 to −.31…−2.66 to −.59−2.45 to −.39−2.40 to −.66
 P Value…<.0001<.0001<.0001….0024.0073.0008
TWA ChangeOverall Study PopulationImmunocompromised Population
Placebo
(n = 633)		CAS + IMD 2.4 g IV (n = 664)CAS + IMD 8.0 g IV (n = 643)CAS + IMD Combined Doses
(n = 1307)		Placebo
(n = 35)		CAS + IMD 2.4 g IV (n = 32)CAS + IMD 8.0 g IV (n = 32)CAS + IMD Combined Doses
(n = 64)
Median baseline VL, log10 copies/mL6.286.356.366.366.897.516.877.36
TWA change from day 1 to day 7
 No.567584572115630302959
 LS mean (SE)−.93 (0.05)−1.27 (.05)−1.21 (.05)−1.24 (.04)−.49 (.29)−1.43 (.28)−.92 (.26)−1.16 (.22)
 95% CI−1.03 to −.83−1.37 to −1.17−1.31 to −1.11−1.32 to −1.16−1.06 to .08−1.99 to −.88−1.44 to −.40−1.59 to −.73
 Difference vs placebo…−.34 (.06)−.28 (.06)−.31 (.06)…−.94 (.32)−.43 (.32)−.69 (.28)
 95% CI…−.47 to −.22−.41 to −.15−.42 to −.20…−1.58 to −.31−1.07 to .20−1.25 to −.14
 P Value…<.0001<.0001<.0001….0041.1801.0146
TWA change from day 1 to day 13
 LS mean (SE)−1.51 (.06)−1.95 (.06)−1.94 (.06)−1.95 (.05)−1.17 (.38)−2.52 (.38)−1.75 (.35)−2.09 (.29)
 95% CI−1.63 to −1.39−2.07 to −1.84−2.06 to −1.82−2.04 to −1.86−1.92 to −.41−3.27 to −1.77−2.45 to −1.06−2.67 to −1.50
 Difference vs placebo…−.45 (.08)−.44 (.08)−.44 (.07)…−1.35 (.42)−.59 (.42)−.96 (.37)
 95% CI…−.60 to −.30−.59 to −.29−.57 to −.31…−2.19 to −.51−1.43 to .26−1.69 to −.23
 P Value…<.0001<.0001<.0001….0021.1699.0107
TWA change from day 1 to day 29
 LS mean (SE)−2.46 (.08)−2.90 (.07)−2.96 (.08)−2.93 (.06)−2.08 (.44)−3.70 (.46)−3.50 (.43)−3.60 (.35)
 95% CI−2.61 to −2.31−3.05 to −2.75−3.11 to −2.82−3.05 to −2.82−2.95 to −1.21−4.62 to −2.79−4.36 to −2.64−4.30 to −2.91
 Difference vs placebo…−.44 (.09)−.50 (.09)−.47 (.08)…−1.62 (.52)−1.42 (.52)−1.53 (.44)
 95% CI…−.62 to −.25−.69 to −.32−.63 to −.31…−2.66 to −.59−2.45 to −.39−2.40 to −.66
 P Value…<.0001<.0001<.0001….0024.0073.0008

Abbreviations: CAS + IMD, casirivimab plus imdevimab; CI, confidence interval; IV, intravenous; LS, least-squares; SE, standard error; TWA, time-weighted average; VL, viral load.

Table 1.
Open in new tab

Time-Weighted Average Change in Viral Load From Baseline in Immunocompromised Patients Compared With the Overall Population

TWA ChangeOverall Study PopulationImmunocompromised Population
Placebo
(n = 633)		CAS + IMD 2.4 g IV (n = 664)CAS + IMD 8.0 g IV (n = 643)CAS + IMD Combined Doses
(n = 1307)		Placebo
(n = 35)		CAS + IMD 2.4 g IV (n = 32)CAS + IMD 8.0 g IV (n = 32)CAS + IMD Combined Doses
(n = 64)
Median baseline VL, log10 copies/mL6.286.356.366.366.897.516.877.36
TWA change from day 1 to day 7
 No.567584572115630302959
 LS mean (SE)−.93 (0.05)−1.27 (.05)−1.21 (.05)−1.24 (.04)−.49 (.29)−1.43 (.28)−.92 (.26)−1.16 (.22)
 95% CI−1.03 to −.83−1.37 to −1.17−1.31 to −1.11−1.32 to −1.16−1.06 to .08−1.99 to −.88−1.44 to −.40−1.59 to −.73
 Difference vs placebo…−.34 (.06)−.28 (.06)−.31 (.06)…−.94 (.32)−.43 (.32)−.69 (.28)
 95% CI…−.47 to −.22−.41 to −.15−.42 to −.20…−1.58 to −.31−1.07 to .20−1.25 to −.14
 P Value…<.0001<.0001<.0001….0041.1801.0146
TWA change from day 1 to day 13
 LS mean (SE)−1.51 (.06)−1.95 (.06)−1.94 (.06)−1.95 (.05)−1.17 (.38)−2.52 (.38)−1.75 (.35)−2.09 (.29)
 95% CI−1.63 to −1.39−2.07 to −1.84−2.06 to −1.82−2.04 to −1.86−1.92 to −.41−3.27 to −1.77−2.45 to −1.06−2.67 to −1.50
 Difference vs placebo…−.45 (.08)−.44 (.08)−.44 (.07)…−1.35 (.42)−.59 (.42)−.96 (.37)
 95% CI…−.60 to −.30−.59 to −.29−.57 to −.31…−2.19 to −.51−1.43 to .26−1.69 to −.23
 P Value…<.0001<.0001<.0001….0021.1699.0107
TWA change from day 1 to day 29
 LS mean (SE)−2.46 (.08)−2.90 (.07)−2.96 (.08)−2.93 (.06)−2.08 (.44)−3.70 (.46)−3.50 (.43)−3.60 (.35)
 95% CI−2.61 to −2.31−3.05 to −2.75−3.11 to −2.82−3.05 to −2.82−2.95 to −1.21−4.62 to −2.79−4.36 to −2.64−4.30 to −2.91
 Difference vs placebo…−.44 (.09)−.50 (.09)−.47 (.08)…−1.62 (.52)−1.42 (.52)−1.53 (.44)
 95% CI…−.62 to −.25−.69 to −.32−.63 to −.31…−2.66 to −.59−2.45 to −.39−2.40 to −.66
 P Value…<.0001<.0001<.0001….0024.0073.0008
TWA ChangeOverall Study PopulationImmunocompromised Population
Placebo
(n = 633)		CAS + IMD 2.4 g IV (n = 664)CAS + IMD 8.0 g IV (n = 643)CAS + IMD Combined Doses
(n = 1307)		Placebo
(n = 35)		CAS + IMD 2.4 g IV (n = 32)CAS + IMD 8.0 g IV (n = 32)CAS + IMD Combined Doses
(n = 64)
Median baseline VL, log10 copies/mL6.286.356.366.366.897.516.877.36
TWA change from day 1 to day 7
 No.567584572115630302959
 LS mean (SE)−.93 (0.05)−1.27 (.05)−1.21 (.05)−1.24 (.04)−.49 (.29)−1.43 (.28)−.92 (.26)−1.16 (.22)
 95% CI−1.03 to −.83−1.37 to −1.17−1.31 to −1.11−1.32 to −1.16−1.06 to .08−1.99 to −.88−1.44 to −.40−1.59 to −.73
 Difference vs placebo…−.34 (.06)−.28 (.06)−.31 (.06)…−.94 (.32)−.43 (.32)−.69 (.28)
 95% CI…−.47 to −.22−.41 to −.15−.42 to −.20…−1.58 to −.31−1.07 to .20−1.25 to −.14
 P Value…<.0001<.0001<.0001….0041.1801.0146
TWA change from day 1 to day 13
 LS mean (SE)−1.51 (.06)−1.95 (.06)−1.94 (.06)−1.95 (.05)−1.17 (.38)−2.52 (.38)−1.75 (.35)−2.09 (.29)
 95% CI−1.63 to −1.39−2.07 to −1.84−2.06 to −1.82−2.04 to −1.86−1.92 to −.41−3.27 to −1.77−2.45 to −1.06−2.67 to −1.50
 Difference vs placebo…−.45 (.08)−.44 (.08)−.44 (.07)…−1.35 (.42)−.59 (.42)−.96 (.37)
 95% CI…−.60 to −.30−.59 to −.29−.57 to −.31…−2.19 to −.51−1.43 to .26−1.69 to −.23
 P Value…<.0001<.0001<.0001….0021.1699.0107
TWA change from day 1 to day 29
 LS mean (SE)−2.46 (.08)−2.90 (.07)−2.96 (.08)−2.93 (.06)−2.08 (.44)−3.70 (.46)−3.50 (.43)−3.60 (.35)
 95% CI−2.61 to −2.31−3.05 to −2.75−3.11 to −2.82−3.05 to −2.82−2.95 to −1.21−4.62 to −2.79−4.36 to −2.64−4.30 to −2.91
 Difference vs placebo…−.44 (.09)−.50 (.09)−.47 (.08)…−1.62 (.52)−1.42 (.52)−1.53 (.44)
 95% CI…−.62 to −.25−.69 to −.32−.63 to −.31…−2.66 to −.59−2.45 to −.39−2.40 to −.66
 P Value…<.0001<.0001<.0001….0024.0073.0008

Abbreviations: CAS + IMD, casirivimab plus imdevimab; CI, confidence interval; IV, intravenous; LS, least-squares; SE, standard error; TWA, time-weighted average; VL, viral load.

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