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A trial of arbidol hydrochloride in adults with COVID-19

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收录情况: ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越:领军期刊 ◇ 中华系列

单位: [1]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China. [2]institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China. [3]Department of Emergency, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China. [4]Department of Respiratory and Critical Care Medicine, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China. [5]Department of Neurology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,China. [6]Department of Respiratory and Critical Care Medicine, Renmin Hospital, Wuhan University, Wuhan, Hubei 430060, China. [7]Department of Endocrinology, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China. [8]Department of Respiratory Medicine, Wuhan Bauhinia Hospital, Wuhan, Hubei 430062, China. [9]Department of Respiratory Medicine, Guanggu Hospital District, The Third Hospital of Wuhan, Wuhan, Hubei 430074, China. [10]Department of Respiratory and Critical Care Medicine, Puren Hospital, Wuhan University of Science and Technology, Wuhan, Hubei 430081, China. [11]Department of Respiratory Medicine, The Third People's Hospital of Hubei Province, Wuhan, Hubei 430030, China. [12]Department of Respiratory Medicine, The Sixth General Hospital of Hubei Province, Wuhan, Hubei 430015, China. [13]Tuberculosis Department of Chengdu Public Health Clinical Medical Center, Chengdu, Sichuan 610066, China. [14]Department of Neurology, Wuhan Red Cross Hospital, Wuhan, Hubei 430015, China. [15]Department of Tuberculosis, Jinyintan Hospital, Wuhan, Hubei 430048, China. [16]Department of Cardiology, The Third People's Hospital of Hubei Province, Wuhan, Hubei 430030, China.
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关键词: Arbidol Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

摘要:
To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs. 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%-48.1%; P  = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs. 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060, P = 0.006), symptom of fever (median 3.0 days vs. 12.0 days; HR: 18.990, 95% CI: 5.350-67.410, P < 0.001), as well as hospitalization (median 12.5 days vs. 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs. 14.5 days; P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression.SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week anas, accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.Chinese Clinical Trial Registry, NCT04260594, www.clinicaltrials.gov/ct2/show/NCT04260594?term=NCT04260594&draw=2&rank=1.Copyright © 2022 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 医学:内科
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 医学:内科
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出版当年[2020]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版:
Q1 MEDICINE, GENERAL & INTERNAL

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第一作者:
第一作者单位: [1]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China. [2]institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.
通讯作者:
通讯机构: [1]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China. [2]institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China. [*1]Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
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