SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial
Fecha
2020Autor
Zheng, Fang
Zhou, Yanwen
Zhou, Zhiguo
Ye, Fei
Huang, Baoying
Huang, Yaxiong
Ma, Jing
Zuo, Qi
Tan, Xin
Xie, Jun
Niu, Peihua
Wang, Wenlong
Xu, Yun
Peng, Feng
Zhou, Ning
Cai, Chunlin
Tang, Wei
Xiao, Xinqiang
Li, Yi
Zhou, Zhiguang
Jiang, Yongfang
Xie, Yuanlin
Tan, Wenjie
Gong, Guozhong
Resumen
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
Palabras clave
COVID-19; SARS-CoV-2; Novaferon; Antiviral drug; Lopinavir/Ritonavir; Viral clearance; Aerosolized inhalationEnlace al recurso
https://doi.org/10.1016/j.ijid.2020.07.053Colecciones
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