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Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19
Bin Cao1, Yeming Wang1, Hongzhou Lu1
1From the Departments of Pulmonary and Critical Care Medicine (B.C., Y.W., L.S., J.X., Chen Wang) and Clinical Research and Data Management (X.G.), Institute of Respiratory Medicine in the Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, National Center for Respiratory Medicine, China-Japan Friendship Hospital, Changping Laboratory (B.C., Chen Wang), the Department of Medicine, Non-oncology, Jiangsu Simcere Pharmaceutical (Y.Y.), Clinical and Research Center of Infectious Diseases Beijing Ditan Hospital, Capital Medical University (R.J.), and Chinese Academy of Medical Sciences and Peking Union Medical College (Chen Wang), Beijing, the Department of Infectious Diseases, Third People's Hospital of Shenzhen, National Clinical Research Center for Infectious Diseases, Shenzhen (H.L., F.W.), Jin Yin-tan Hospital (C.H., F.G.) and Wuhan Institute of Virology, Chinese Academy of Sciences (L.Z.), Wuhan, the Public Health Clinical Center of Chengdu, Chengdu (Z.C.), Tianjin First Central Hospital, Tianjin (Y.L.), the Department of Cardiology, Hainan Third People's Hospital, Sanya (L.L.), the Department of Respiratory Medicine, Guangzhou Eighth People's Hospital, Guangzhou (P.P.), the Department of Clinical Statistics and Data Management, Jiangsu Simcere Pharmaceutical (H.H.), the Department of Infection and Immunity, Shanghai Public Health Clinical Center (Y.S.), and the Department of Infectious Diseases, Zhongshan Hospital (B.H.), Fudan University, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences (J.S., Y.X.), and the Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion of the Ministry of Education (J.F.), Shanghai, the Second Hospital of Nanjing (C.C.), Jiangsu Simcere Pharmaceutical (R.T.), and State Key Laboratory of Neurology and Oncology Drug Development (R.T.), Nanjing, the First Affiliated Hospital of Xiamen University, Xiamen (X. Yao), Guizhou Provincial People's Hospital, Guiyang (X. Ye, H.Z.), the Second Department of Infection, Shandong Public Health Clinical Center, Jinan (C.L.), Xuzhou Infectious Diseases Hospital, Xuzhou (Chunying Wang), and Central People's Hospital of Zhanjiang, Zhanjiang (Z.Y.) - all in China.
Background:
Simnotrelvir is an oral 3-chymotrypsin-like protease inhibitor that has been found to have in vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential efficacy in a phase 1B trial.
Methods:
In this phase 2-3, double-blind, randomized, placebo-controlled trial, we assigned patients who had mild-to-moderate coronavirus disease 2019 (Covid-19) and onset of symptoms within the past 3 days in a 1:1 ratio to receive 750 mg of simnotrelvir plus 100 mg of ritonavir or placebo twice daily for 5 days. The primary efficacy end point was the time to sustained resolution of symptoms, defined as the absence of 11 Covid-19-related symptoms for 2 consecutive days. Safety and changes in viral load were also assessed.
Results:
A total of 1208 patients were enrolled at 35 sites in China; 603 were assigned to receive simnotrelvir and 605 to receive placebo. Among patients in the modified intention-to-treat population who received the first dose of trial drug or placebo within 72 hours after symptom onset, the time to sustained resolution of Covid-19 symptoms was significantly shorter in the simnotrelvir group than in the placebo group (180.1 hours [95% confidence interval {CI}, 162.1 to 201.6] vs. 216.0 hours [95% CI, 203.4 to 228.1]; median difference, -35.8 hours [95% CI, -60.1 to -12.4]; P = 0.006 by Peto-Prentice test). On day 5, the decrease in viral load from baseline was greater in the simnotrelvir group than in the placebo group (mean difference [±SE], -1.51±0.14 log10 copies per milliliter; 95% CI, -1.79 to -1.24). The incidence of adverse events during treatment was higher in the simnotrelvir group than in the placebo group (29.0% vs. 21.6%). Most adverse events were mild or moderate.
Conclusions:
Early administration of simnotrelvir plus ritonavir shortened the time to the resolution of symptoms among adult patients with Covid-19, without evident safety concerns. (Funded by Jiangsu Simcere Pharmaceutical; ClinicalTrials.gov number, NCT05506176.).
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