Dataset Information

SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.

ABSTRACT:

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=1.02ng/ml), and prevented viral infection (EC₅₀=0.10ng/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/).

SUBMITTER: Zheng F

PROVIDER: S-EPMC7397938 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.

Zheng Fang F Zhou Yanwen Y Zhou Zhiguo Z Ye Fei F Huang Baoying B Huang Yaxiong Y Ma Jing J Zuo Qi Q Tan Xin X Xie Jun J Niu Peihua P Wang Wenlong W Xu Yun Y Peng Feng F Zhou Ning N Cai Chunlin C Tang Wei W Xiao Xinqiang X Li Yi Y Zhou Zhiguang Z Jiang Yongfang Y Xie Yuanlin Y Tan Wenjie W Gong Guozhong G

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 20200803

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 32758689

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Dataset Information

SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.

Background

Methods

Results

Conclusions

Trial registration number

Publications

SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.

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