A Randomized, Open-Label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, a Pilot Study

被引：147

作者：

Ren, Zhigang ^{[1
,2
]}

Luo, Hong ^{[2
]}

Yu, Zujiang ^{[1
]}

Song, Jingchao ^{[3
,4
]}

Liang, Lan ^{[5
]}

Wang, Ling ^{[6
]}

Wang, Haiyu ^{[1
]}

Cui, Guangying ^{[1
]}

Liu, Yong ^{[7
]}

Wang, Jin ^{[8
]}

Li, Qingquan ^{[4
]}

Zeng, Zhaohai ^{[2
]}

Yang, Shengkun ^{[2
]}

Pei, Guangzhong ^{[2
]}

Zhu, Yonghui ^{[2
,3
]}

Song, Wenbin ^{[2
]}

Yu, Wenquan ^{[9
]}

Song, Chuanjun ^{[9
]}

Dong, Lihong ^{[9
]}

Hu, Chuansong ^{[2
]}

Du, Jinfa ^{[7
]}

Chang, Junbiao ^{[5
,9
]}

机构：

[1] Zhengzhou Univ, Dept Infect Dis, Affiliated Hosp 1, Zhengzhou 450052, Peoples R China

[2] Guangshan Cty Peoples Hosp, Xinyang 465450, Guangshan Count, Peoples R China

[3] Henan Prov Chest Hosp, Dept Thorac Surg, Zhengzhou 450008, Peoples R China

[4] Xixian Peoples Hosp, Med Dept, Xixian 464300, Xinyang, Peoples R China

[5] Henan Normal Univ, Sch Chem & Chem Engn, Henan Key Lab Organ Funct Mol & Drug Innovat, Xinxiang 453007, Henan, Peoples R China

[6] Henan Prov Chest Hosp, Dept Clin Lab, Zhengzhou 450008, Peoples R China

[7] Henan Genuine Biotech Co Ltd, 10 Fuxing Rd, Pingdingshan 467036, Henan, Peoples R China

[8] Huangchuan Cty Peoples Hosp, Dept Orthoped, Xinyang 465150, Huangchuan Coun, Peoples R China

[9] Zhengzhou Univ, Henan New Drug Creat & Drug Safety Evaluat Collab, Zhengzhou 450001, Peoples R China

来源：

ADVANCED SCIENCE | 2020年 / 7卷 / 19期

基金：

中国国家自然科学基金;

关键词：

azvudine; COVID-19; SARS-CoV-2; NUCLEOSIDE; ANALOGS;

D O I：

10.1002/advs.202001435

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

Coronavirus disease 2019 (COVID-19) has spread worldwide. To date, no specific drug for COVID-19 has been developed. Thus, this randomized, open-label, controlled clinical trial (ChiCTR2000029853) was performed in China. A total of 20 mild and common COVID-19 patients were enrolled and randomly assigned to receive azvudine and symptomatic treatment (FNC group), or standard antiviral and symptomatic treatment (control group). The mean times of the first nucleic acid negative conversion (NANC) of ten patients in the FNC group and ten patients in the control group are 2.60 (SD 0.97; range 1-4) d and 5.60 (SD 3.06; range 2-13) d, respectively (p= 0.008). The mean times of the first NANC of four newly diagnosed subjects in the FNC group and ten subjects in the control group are 2.50 (SD 1.00; range 2-4) d and 9.80 (SD 4.73; range 3-19) d, respectively (starting from the initial treatment) (p= 0.01). No adverse events occur in the FNC group, while three adverse events occur in the control group (p= 0.06). The preliminary results show that FNC treatment in the mild and common COVID-19 may shorten the NANC time versus standard antiviral treatment. Therefore, clinical trials of FNC treating COVID-19 with larger sample size are warranted.

引用

页数：10

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