The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol

The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an o...

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Published inEngineering (Beijing, China) Vol. 6; no. 10; pp. 1199 - 1204
Main Authors Wu, Xiaoke, Yu, Kaijiang, Wang, Yongchen, Xu, Wanhai, Ma, Hongli, Hou, Yan, Li, Yue, Cai, Benzhi, Zhu, Liying, Zhang, Min, Hu, Xiaoli, Gao, Jingshu, Wang, Yu, Qin, Huichao, Zhao, Mingyan, Zhang, Yong, Li, Kang, Du, Zhimin, Yang, Baofeng
Format Journal Article
LanguageEnglish
Published Elsevier Ltd 01.10.2020
THE AUTHORS. Published by Elsevier LTD on behalf of Chinese Academy of Engineering and Higher Education Press Limited Company
Elsevier
Subjects
Online AccessGet full text
ISSN2095-8099
2096-0026
DOI10.1016/j.eng.2020.06.011

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Abstract The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.
AbstractList The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.
The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.
Author Wang, Yongchen
Li, Kang
Wang, Yu
Yu, Kaijiang
Ma, Hongli
Zhu, Liying
Zhao, Mingyan
Hou, Yan
Zhang, Min
Cai, Benzhi
Qin, Huichao
Hu, Xiaoli
Yang, Baofeng
Li, Yue
Gao, Jingshu
Wu, Xiaoke
Xu, Wanhai
Du, Zhimin
Zhang, Yong
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  organization: Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China
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  organization: First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China
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  surname: Zhang
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  givenname: Kang
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  organization: The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China
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  givenname: Baofeng
  surname: Yang
  fullname: Yang, Baofeng
  email: yangbf@ems.hrbmu.edu.cn
  organization: Department of Pharmacology & State–Province Key Laboratories of Biomedicine-Pharmaceutics of China & Key Laboratory of Cardiovascular Medicine Research, Ministry of Education, College of Pharmacology, Harbin Medical University, Harbin 150001, China
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Keywords Efficacy
Pneumonia
SARS-CoV-2
Safety
Coronavirus disease 2019
Triazavirin
Language English
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Snippet The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has...
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SubjectTerms Coronavirus disease 2019
Efficacy
Pneumonia
Research Coronavirus Disease 2019—Protocol
Safety
SARS-CoV-2
Triazavirin
Title The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol
URI https://dx.doi.org/10.1016/j.eng.2020.06.011
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