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

DOI record: { "DOI": "10.1002/advs.202001435", "ISSN": [ "2198-3844", "2198-3844" ], "URL": "http://dx.doi.org/10.1002/advs.202001435", "abstract": "<jats:title>Abstract</jats:title><jats:p>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 (<jats:italic>p</jats:italic> = 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) (<jats:italic>p</jats:italic> = 0.01). No adverse events occur in the FNC group, while three adverse events occur in the control group (<jats:italic>p</jats:italic> = 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.</jats:p>", "alternative-id": [ "10.1002/advs.202001435" ], "assertion": [ { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Received", "name": "received", "order": 0, "value": "2020-04-19" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Published", "name": "published", "order": 2, "value": "2020-08-13" } ], "author": [ { "affiliation": [ { "name": "Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China" }, { "name": "Guangshan County People's Hospital Guangshan County Xinyang 465450 China" } ], "family": "Ren", "given": "Zhigang", "sequence": "first" }, { "affiliation": [ { "name": "Guangshan County People's Hospital Guangshan County Xinyang 465450 China" } ], "family": "Luo", "given": "Hong", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China" } ], "family": "Yu", "given": "Zujiang", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Thoracic Surgery Henan Provincial Chest Hospital Zhengzhou 450008 China" }, { "name": "Medical Department Xixian people's Hospital Xixian Xinyang 464300 China" } ], "family": "Song", "given": "Jingchao", "sequence": "additional" }, { "affiliation": [ { "name": "Henan Key Laboratory of Organic Functional Molecule and Drug Innovation School of Chemistry and Chemical Engineering Henan Normal University Xinxiang 453007 China" } ], "family": "Liang", "given": "Lan", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Clinical Laboratory Henan Provincial Chest Hospital Zhengzhou 450008 China" } ], "family": "Wang", "given": "Ling", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China" } ], "family": "Wang", "given": "Haiyu", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Infectious Diseases the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China" } ], "family": "Cui", "given": "Guangying", "sequence": "additional" }, { "affiliation": [ { "name": "Henan Genuine Biotech Co., Ltd. 10 Fuxing Road, Xincheng District Pingdingshan Henan 467036 China" } ], "family": "Liu", "given": "Yong", "sequence": "additional" }, { "affiliation": [ { "name": "Department of Orthopedics Huangchuan County People's Hospital Huangchuan County Xinyang 465150 China" } ], "family": "Wang", "given": "Jin", "sequence": "additional" }, { "affiliation": [ { "name": "Medical Department Xixian people's Hospital Xixian Xinyang 464300 China" } ], "family": "Li", "given": "Qingquan", "sequence": "additional" }, { "affiliation": [ { "name": "Guangshan County People's Hospital Guangshan County Xinyang 465450 China" 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