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/).

• Authors: 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
• Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases (Int J Infect Dis) Vol. 99 Pg. 84-91 (Oct 2020) ISSN: 1878-3511 [Electronic] Canada
• PMID: 32758689 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antiviral Agents
• Recombinant Proteins
• Interferons
• recombinant interferon alpha 2b-like protein

Topics

• Administration, Inhalation
• Antiviral Agents (administration & dosage, therapeutic use)
• Betacoronavirus (drug effects)
• COVID-19
• Coronavirus Infections (drug therapy)
• Female
• Humans
• Interferons (administration & dosage, therapeutic use)
• Male
• Pandemics
• Pneumonia, Viral (drug therapy)
• Recombinant Proteins (administration & dosage, therapeutic use)
• SARS-CoV-2
• Virus Replication (drug effects)
• COVID-19 Drug Treatment