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. 2020 Oct;7(19):e2001435.
doi: 10.1002/advs.202001435. Epub 2020 Aug 13.

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

Zhigang Ren  1   2 , Hong Luo  2 , Zujiang Yu  1 , Jingchao Song  3   4 , Lan Liang  5 , Ling Wang  6 , Haiyu Wang  1 , Guangying Cui  1 , Yong Liu  7 , Jin Wang  8 , Qingquan Li  4 , Zhaohai Zeng  2 , Shengkun Yang  2 , Guangzhong Pei  2 , Yonghui Zhu  2   3 , Wenbin Song  2 , Wenquan Yu  9 , Chuanjun Song  9 , Lihong Dong  9 , Chuansong Hu  2 , Jinfa Du  7 , Junbiao Chang  5   9
Affiliations

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

Zhigang Ren et al. Adv Sci (Weinh). 2020 Oct.

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; azvudine.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Trial profile.
Figure 2
Figure 2
Kaplan–Meier curves of two consecutive nucleic acid testing negativity for a) the first and b) the second nucleic acid testing negativity in the FNC group and control group. Data are shown for ten patients assigned to FNC group and ten assigned to control group. Data are percentage (%). The differences between groups were using Log‐rank (Mantel‐Cox) test. On the fourth day after treatment, the rate of first negative conversion of nucleic acid achieved 100% in patients from the FNC group and 30% in patients from the control group. The Kaplan–Meier curves indicate the significant difference (p = 0.0013). On the sixth day, the rate of second nucleic acid negative conversion achieved 100% in patients from the FNC group and 40% in patients from the control group. The Kaplan–Meier curves indicate the significant difference (p = 0.0011). NAT, nucleic acid testing.
Figure 3
Figure 3
Comparison of the time of the first and the second nucleic acid testing negativity between a) all subjects in the FNC group and the control group (starting from the enrollment); b) four newly confirmed subjects in the FNC group and ten subjects in the control group (starting from the initial treatment); c) six treated subjects in the FNC group and six treated subjects in the control group (starting from the enrollment). Data are mean (SD). The differences between groups were analyzed using Student's t‐test. *p < 0.05, **p < 0.01, and ***p < 0.001. FNC, azvudine; first neg, first nucleic acid testing negativity; second neg, second nucleic acid testing negativity.
Figure 4
Figure 4
Secondary outcomes. a) Pneumonia incidence between eight subjects in the FNC group and eight subjects in the control group. Data are percentages (%). The differences between groups were analyzed using Log‐rank (Mantel–Cox) test. The pneumonia improvement time were shortened in the FNC group versus control group (p = 0.0401). b) The dynamic changes in body temperature of ten patients in the FNC and ten patients in the control group during the treatment. Data are mean (SD).
Figure 5
Figure 5
Safety and adverse events. During the treatment, the dynamic changes in a) heart rate, b) respiratory rate, c) systolic pressure, d) diastolic pressure, e) ALT, f) AST, g) GGT, h) total bilirubin, i) BUN, and j) creatinine of ten patients in the FNC group and ten patients in the control group. Data are mean (SD). ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, glutamyl transpeptidase; BUN, blood urea nitrogen. k) Comparison of adverse events incidence of ten patients in the FNC group and ten patients in the control group. Data are percentages (%). The adverse event incidence was decreased in the FNC group (0%) versus the control group (30%) (p = 0.06).
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