SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial
Background: The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial. Methods: In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and pre...
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Elsevier
2020-10-01
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Series: | International Journal of Infectious Diseases |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S120197122030597X |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Fang Zheng Yanwen Zhou Zhiguo Zhou Fei Ye Baoying Huang Yaxiong Huang Jing Ma Qi Zuo Xin Tan Jun Xie Peihua Niu Wenlong Wang Yun Xu Feng Peng Ning Zhou Chunlin Cai Wei Tang Xinqiang Xiao Yi Li Zhiguang Zhou Yongfang Jiang Yuanlin Xie Wenjie Tan Guozhong Gong |
spellingShingle |
Fang Zheng Yanwen Zhou Zhiguo Zhou Fei Ye Baoying Huang Yaxiong Huang Jing Ma Qi Zuo Xin Tan Jun Xie Peihua Niu Wenlong Wang Yun Xu Feng Peng Ning Zhou Chunlin Cai Wei Tang Xinqiang Xiao Yi Li Zhiguang Zhou Yongfang Jiang Yuanlin Xie Wenjie Tan Guozhong Gong SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial International Journal of Infectious Diseases COVID-19 SARS-CoV-2 Novaferon Antiviral drug Lopinavir/Ritonavir Viral clearance |
author_facet |
Fang Zheng Yanwen Zhou Zhiguo Zhou Fei Ye Baoying Huang Yaxiong Huang Jing Ma Qi Zuo Xin Tan Jun Xie Peihua Niu Wenlong Wang Yun Xu Feng Peng Ning Zhou Chunlin Cai Wei Tang Xinqiang Xiao Yi Li Zhiguang Zhou Yongfang Jiang Yuanlin Xie Wenjie Tan Guozhong Gong |
author_sort |
Fang Zheng |
title |
SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial |
title_short |
SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial |
title_full |
SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial |
title_fullStr |
SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial |
title_full_unstemmed |
SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial |
title_sort |
sars-cov-2 clearance in covid-19 patients with novaferon treatment: a randomized, open-label, parallel-group trial |
publisher |
Elsevier |
series |
International Journal of Infectious Diseases |
issn |
1201-9712 |
publishDate |
2020-10-01 |
description |
Background: The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial. Methods: In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance. Results: Novaferon inhibited viral replication (EC50 = 1.02 ng/ml), and prevented viral infection (EC50 = 0.10 ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p = 0.0400, and 60.0% vs. 24.1%, p = 0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group. Conclusions: Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon. Trial registration number: Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/). |
topic |
COVID-19 SARS-CoV-2 Novaferon Antiviral drug Lopinavir/Ritonavir Viral clearance |
url |
http://www.sciencedirect.com/science/article/pii/S120197122030597X |
work_keys_str_mv |
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doaj-e10c7850580e469a9e23114d620479d92020-11-25T03:55:00ZengElsevierInternational Journal of Infectious Diseases1201-97122020-10-01998491SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trialFang Zheng0Yanwen Zhou1Zhiguo Zhou2Fei Ye3Baoying Huang4Yaxiong Huang5Jing Ma6Qi Zuo7Xin Tan8Jun Xie9Peihua Niu10Wenlong Wang11Yun Xu12Feng Peng13Ning Zhou14Chunlin Cai15Wei Tang16Xinqiang Xiao17Yi Li18Zhiguang Zhou19Yongfang Jiang20Yuanlin Xie21Wenjie Tan22Guozhong Gong23Department of Infectious Diseases, The First Hospital of Changsha, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Respiratory Medicine, The First Hospital of Changsha, Changsha, ChinaNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaDepartment of Infectious Diseases, The First Hospital of Changsha, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Intensive Care Unit, The First Hospital of Changsha, Changsha, ChinaDepartment of Pediatrics, The First Hospital of Changsha, Changsha, ChinaDepartment of Internal Medicine, The First Hospital of Changsha, Changsha, ChinaNational Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The First Hospital of Changsha, Changsha, ChinaDepartment of Infectious Diseases, The First Hospital of Changsha, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaKey Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China; Corresponding authors at: Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha 410011, China.Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China; Corresponding authors at: Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha 410011, China.National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China; Corresponding authors at: Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha 410011, China.Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China; Corresponding authors at: Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha 410011, China.Background: The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial. Methods: In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance. Results: Novaferon inhibited viral replication (EC50 = 1.02 ng/ml), and prevented viral infection (EC50 = 0.10 ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p = 0.0400, and 60.0% vs. 24.1%, p = 0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group. Conclusions: Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon. Trial registration number: Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).http://www.sciencedirect.com/science/article/pii/S120197122030597XCOVID-19SARS-CoV-2NovaferonAntiviral drugLopinavir/RitonavirViral clearance |