2020, Volume 6, Issue 10
Engineering >> 2020, Volume 6, Issue 10 doi: 10.1016/j.eng.2020.06.011
The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol
a 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
b First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China
c The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China
d The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China
e The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China
f Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China
# These authors contributed equally to this work.
Next Previous
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.
Keywords
Coronavirus disease 2019 ; Pneumonia ; SARS-CoV-2 ; Triazavirin ; Efficacy ; Safety
Figures
Fig. 1
References
[ 1 ] Chen S, Yang J, Yang W, Wang C, Bärnighausen T. COVID-19 control in China during mass population movements at New Year. Lancet 2020;395 (10226):764–6. link1
[ 2 ] Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect 2020;9(1):386–9. link1
[ 3 ] Coronavirus disease (COVID-19) pandemic [Internet]. Geneva: World Health Organization; c2020 [cited 2020 Mar 11]. Available from: https://www.who. int/emergencies/diseases/novel-coronavirus-2019.
[ 4 ] nhc.gov.cn [Internet]. Beijing: National Health Commission of the People’s Republic of China; [cited 2020 Mar 12]. Available from: http://www.nhc.gov. cn/xcs/yqtb/202003/37c1536b6655473f8c2120ebdc475731.shtml. Chinese.
[ 5 ] Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA 2020;323(11):1061–9. link1
[ 6 ] Guan W, Ni Z, Hu Y, Liang W, Qu C, He J, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:1708–20. link1
[ 7 ] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395 (10223):497–506. link1
[ 8 ] Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 2020;30:269–71. link1
[ 9 ] National Health Commission of the People’s Republic of China, National Administration of Traditional Chinese Medicine. Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 7). Chin Med J 2020;133:1087–95.
[10] Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends 2020;14:69–71. link1
[11] Karpenko I, Deev S, Kiselev O, Charushin V, Rusinov V, Ulomsky E, et al. Antiviral properties, metabolism, and pharmacokinetics of a novel azolo-1,2,4- triazine-derived inhibitor of influenza A and B virus replication. Antimicrob Agents Chemother 2010;54(5):2017–22. link1
[12] Loginova SY, Borisevich SV, Rusinov VL, Ulomskii UN, Charushin VN, Chupakhin ON. Investigation of Triazavirin antiviral activity against tickborne encephalitis pathogen in cell culture. Antibiot Khimioter 2014;59(1– 2):3–5. link1
[13] Loginova SY, Borisevich SV, Rusinov VL, Ulomsky UN, Charushin VN, Chupakhin N, et al. Investigation of prophylactic efficacy of Triazavirin against experimental forest-spring encephalitis on albino mice. Antibiot Khimioter 2015;60(5–6):8–11. link1
[14] Kiselev OI, Deeva EG, Mel’nikova TI, Kozeletskaia KN, Kiselev AS, Rusinov VL, et al. A new antiviral drug Triazavirin: results of phase II clinical trial. Vopr Virusol 2012;57(6):9–12. link1
[15] Tikhonova EP, Kuz’mina TY, Andronova NV, Tyushevskaya OA, Elistratova TA, Kuz’min AE. Study of effectiveness of antiviral drugs (umifenovir, triazavirin) against acute respiratory viral infections. Kazanskiĭ Meditsinskiĭ Zhurnal 2018;99(2):215–23. link1
[16] National Health Commission of the People’s Republic of China, National Administration of Traditional Chinese Medicine. Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 5). Beijing: The State Council of the People’s Republic of China; 2020 Feb 4 [cited 2020 Mar 11]. Available from: http://www.gov.cn/zhengce/zhengceku/2020-02/05/ 5474791/files/de44557832ad4be1929091dcbcfca891.pdf. Chinese.
[17] Gordon CJ, Tchesnokov EP, Feng JY, Porter DP, Götte M. The antiviral compound remdesivir potently inhibits RNA-dependent RNA polymerase from Middle East respiratory syndrome coronavirus. J Biol Chem 2020;295:4773–9. link1
[18] Sheahan TP, Sims AC, Leist SR, Schäfer A, Won J, Brown AJ, et al. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun 2020;11 (1):222. link1
京公网安备 11010502051620号
