Background WXSH0208 is a selective inhibitor of influenza RNA polymerase subunit, demonstrating antiviral activity in preclinical studies against influenza A and B virus infections. The purpose of this study was to investigate the efficacy and safety of WXSH0208 in adult outpatients with uncomplicated influenza. Methods We conducted a multicenter phase 2 trial based on a randomized, double-blind, placebo-controlled design at 23 research centers in China from November 2023 to March 2024. Participants were randomized 1:1:1:1 to receive one of the following treatments within 48 hours of symptom onset: WXSH0208 10 mg once daily for 5 days, 20 mg once daily for 5 days, 30 mg once daily for 3 days, or placebo. The primary outcome was the time to negative detection of viral load by reverse transcriptase quantitative polymerase chain reaction in the intention-to-treat infected population. Results Of 240 randomized patients, 209 were included in the intention-to-treat infected analysis. The median time to negative detection of viral load was 49.3 hours in the WXSH0208 10 mg group, 48.0 hours in the 20 mg group, and 48.2 hours in the 30 mg group, as compared with 95.6 hours in the placebo group (P < .001). Time to alleviation of influenza symptoms was comparable among all groups. Treatment-emergent adverse events were reported in 48.3% to 51.7% of WXSH0208 recipients and 58.3% of placebo recipients, with most being mild or moderate in severity. Conclusions WXSH0208 showed no evident safety concerns and was superior to placebo in reducing viral load in adult outpatients with uncomplicated influenza. Clinical Trials Registration. CTR20233250 (www.chinadrugtrials.org.cn).
[1]Chinese Acad Med Sci, Natl Ctr Resp Med, Natl Clin Res Ctr Resp Dis,China-Japan Friendship, State Key Lab Resp Hlth & Multimorbid,Inst Resp Me, Beijing, Peoples R China.
[2]China Japan Friendship Hosp, Ctr Resp Med, Dept Pulm & Crit Care Med, Beijing, Peoples R China.
[3]Loudi Cent Hosp, Dept Infect Dis, Loudi, Peoples R China.
[4]Yichang Cent Peoples Hosp, Dept Resp & Crit Care Med, Yichang, Peoples R China.
[5]Luoyang First Peoples Hosp, Luoyang, Peoples R China.
[6]Hunan Univ Med, Dept Infect Dis, Gen Hosp, Huaihua, Peoples R China.
[7]Univ Elect Sci & Technol China, Sichuan Prov Peoples Hosp, Dept Pulm & Crit Care Med, Chengdu, Peoples R China.
[8]Gannan Med Univ, Affiliated Hosp 1, Dept Resp & Crit Care Med, Ganzhou, Peoples R China.
[9]Guangzhou Med Univ, Affiliated Hosp 2, Dept Pulm & Crit Care Med, Guangzhou, Peoples R China.
[10]Hebei North Univ, Affiliated Hosp 1, Dept Pulm & Crit Care Med, Zhangjiakou, Peoples R China.
[11]Sanmenxia Cent Hosp, Dept Pulm & Crit Care Med, Sanmenxia, Peoples R China.
[12]Suining Cent Hosp, Dept Pulm & Crit Care Med, Suining, Peoples R China.
[13]Jiangmen Cent Hosp, Dept Infect Dis, Jiangmen, Peoples R China.
[14]Shenzhen Nanshan Peoples Hosp, Dept Infect Dis, Shenzhen, Peoples R China.
[15]Capital Med Univ, Beijing Luhe Hosp, Dept Pulm & Crit Care Med, Beijing, Peoples R China.
[16]Zibo Municipal Hosp, Dept Pulm & Crit Care Med, Dept Clin Microbiol, Zibo City Key Lab Resp Infect & Clin Microbiol, Zibo, Peoples R China.
[17]Chengdu Univ Tradit Chinese Med, Dept Resp & Crit Care Med, Chengdu Peoples Hosp 5, Clin Med Coll 2,Affiliated Peoples Hosp 5, Chengdu, Peoples R China.
[18]Nanyang Med Coll, Affiliated Hosp 1, Dept Infect Dis, Nanyang, Peoples R China.
[19]Tianjin Fourth Cent Hosp, Dept Respirat, Tianjin, Peoples R China.
[20]Daqing Peoples Hosp, Dept Cardiovasc Med, Daqing 163316, Heilongjiang, Peoples R China.
[21]Henan Univ Chinese Med, Affiliated Hosp 1, Dept Resp & Crit Care Med, Zhengzhou, Peoples R China.
[22]Guangzhou Med Univ, Affiliated Hosp 5, Dept Resp & Crit Care Med, Guangzhou, Peoples R China.
[23]Anhui Med Univ, Affiliated Hosp 1, Dept Resp & Crit Care Med, Hefei, Peoples R China.
[24]Shandong Prov Clin Ctr Publ Hlth, Observat Ward, Jinan, Peoples R China.
(8.0+极速模式)