Table 2. Change From Baseline to Day 4 in SARS-CoV-2 RNA Levels, Time to Resolution of 12 COVID-19 Symptoms, and Time to Resolution of 14 COVID-19 Symptoms^a.

Variable	Ensitrelvir, 125 mg (n = 347)b	Ensitrelvir, 250 mg (n = 340)	Placebo (n = 343)
Change from baseline to day 4 in SARS-CoV-2 RNA level
Patients, No.	340	333	337
LS mean (SE), log10 copies/mLc	−2.48 (0.08)	−2.49 (0.08)	−1.01 (0.08)
Difference from placebo, LS mean (SE) [95% CI], log10 copies/mLc	−1.47 (0.08) [−1.63 to −1.31]	−1.48 (0.08) [−1.64 to −1.32]	NA
P valuec	<.001	<.001	NA
Time to resolution of 12 COVID-19 symptomsd
Patients, No	336	330	321
Median (95% CI), h	179.2 (152.1 to 212.1)	184.9 (168.9 to 226.2)	213.2 (185.8 to 253.8)
Difference from placebo, median (95% CI), h	−34.0 (−85.9 to 8.3)	−28.3 (−72.8 to 14.7)	NA
P valuee	.07	.08
Time to resolution of 14 COVID-19 symptomsf
Patients, No.	336	330	321
Median (95% CI), h	187.8 (156.4 to 217.0)	190.3 (171.4 to 244.0)	231.8 (192.1 to 265.8)
Difference from placebo, median (95% CI), h	−44.1 (−95.3 to 4.5)	−41.5 (−81.2 to 27.3)	NA
P valuee	.03	.05	NA

Abbreviations: LS, least-squares; NA, not applicable.

^a Results are for the intention-to-treat population of patients randomized in less than 72 hours of disease onset.

^b Primary analysis population.

^c Analysis of covariance using baseline SARS-CoV-2 RNA and SARS-CoV-2 vaccination history (yes or no) as covariates.

^d Low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath (difficulty breathing), nausea, vomiting, and diarrhea.

^e Based on a Peto-Prentice generalized Wilcoxon test stratified by SARS-CoV-2 vaccination history (yes or no).

^f Low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath (difficulty breathing), nausea, vomiting, diarrhea, anosmia, and dysgeusia.