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0 0.5 1 1.5 2+ Change in viral titer, 25.. 45% primary Improvement Relative Risk Change in viral titer, 12.. 36% primary Time to viral-, 125mg 45% Time to viral-, 250mg 44% Viral clearance, 250mg.. 54% Viral clearance, 125mg.. -10% Viral clearance, 250mg, D9 80% Viral clearance, 125mg, D9 54% Viral clearance, 250mg, D6 54% Viral clearance, 125mg, D6 90% Viral clearance, 250mg, D4 80% Viral clearance, 125mg, D4 63% Viral clearance, 250mg, D2 9% Viral clearance, 125mg, D2 -10% c19early.com/en Mukae et al. jRCT2031210350 Ensitrelvir RCT EARLY Favors ensitrelvir Favors control
Mukae, 69 patient ensitrelvir early treatment RCT: 45% improved viral clearance [p=0.002] https://c19p.org/mukae
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A Randomized Phase 2/3 Study of Ensitrelvir, a Novel Oral SARS-CoV-2 3C-like Protease Inhibitor, in Japanese Patients With Mild-to-Moderate COVID-19 or Asymptomatic SARS-CoV-2 Infection: Results of the Phase 2a Part
Mukae et al., medRxiv, doi:10.1101/2022.05.17.22275027 (Preprint)
17 May 2022    Source   PDF   Share   Tweet
RCT 69 patients in in Japan, showing faster viral clearance with ensitrelvir. 5-day ensitrelvir (375mg on day 1 followed by 125 mg daily or 750mg on day 1 followed by 250mg daily).
relative change in viral titer, 45.2% better, RR 0.55, p = 0.002, treatment mean 2.81 (±1.21) n=14, control mean 1.54 (±0.74) n=14, day 4, 250mg, primary outcome.
relative change in viral titer, 36.4% better, RR 0.64, p = 0.048, treatment mean 2.42 (±1.42) n=15, control mean 1.54 (±0.74) n=14, day 4, 125mg, primary outcome.
time to viral-, 44.8% lower, relative time 0.55, p = 0.02, treatment 15, control 14, 125mg.
time to viral-, 43.6% lower, relative time 0.56, p = 0.02, treatment 13, control 14, 250mg.
risk of no viral clearance, 54.2% lower, RR 0.46, p = 0.59, treatment 1 of 12 (8.3%), control 2 of 11 (18.2%), NNT 10, day 14, 250mg, Figure S1.
risk of no viral clearance, 10.0% higher, RR 1.10, p = 1.00, treatment 3 of 15 (20.0%), control 2 of 11 (18.2%), day 14, 125mg, Figure S1.
risk of no viral clearance, 80.0% lower, RR 0.20, p = 0.48, treatment 0 of 13 (0.0%), control 2 of 13 (15.4%), NNT 6.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 9, 250mg, Figure S1.
risk of no viral clearance, 53.6% lower, RR 0.46, p = 0.60, treatment 1 of 14 (7.1%), control 2 of 13 (15.4%), NNT 12, day 9, 125mg, Figure S1.
risk of no viral clearance, 53.6% lower, RR 0.46, p = 0.38, treatment 2 of 14 (14.3%), control 4 of 13 (30.8%), NNT 6.1, day 6, 250mg, Figure S1.
risk of no viral clearance, 89.6% lower, RR 0.10, p = 0.03, treatment 0 of 15 (0.0%), control 4 of 13 (30.8%), NNT 3.2, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 6, 125mg, Figure S1.
risk of no viral clearance, 80.0% lower, RR 0.20, p = 0.006, treatment 2 of 14 (14.3%), control 10 of 14 (71.4%), NNT 1.8, day 4, 250mg, Figure S1.
risk of no viral clearance, 62.7% lower, RR 0.37, p = 0.03, treatment 4 of 15 (26.7%), control 10 of 14 (71.4%), NNT 2.2, day 4, 125mg, Figure S1.
risk of no viral clearance, 9.1% lower, RR 0.91, p = 1.00, treatment 10 of 14 (71.4%), control 11 of 14 (78.6%), NNT 14, day 2, 250mg, Figure S1.
risk of no viral clearance, 10.3% higher, RR 1.10, p = 0.65, treatment 13 of 15 (86.7%), control 11 of 14 (78.6%), day 2, 125mg, Figure S1.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Mukae et al., 5/17/2022, Double Blind Randomized Controlled Trial, placebo-controlled, Japan, Asia, preprint, 13 authors, study period 28 September, 2021 - 1 January, 2022, trial jRCT2031210350.
Contact: takeki.uehara@shionogi.co.jp.
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