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SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial
Fang Zheng1, Yanwen Zhou2, Zhiguo Zhou3
1Department of Infectious Diseases, The First Hospital of Changsha, Changsha, 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=1.02ng/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/).
Insights
Novaferon demonstrates significant antiviral activity against SARS-CoV-2 in laboratory settings and COVID-19 patients. This potent antiviral protein drug accelerates viral clearance, supporting its further clinical evaluation.
Area of Science:
- Virology
- Infectious Diseases
- Pharmacology
Background:
- Novaferon is a potent antiviral protein drug.
- The study evaluated Novaferon's efficacy against COVID-19.
- The trial was registered under ChiCTR2000029496.
Purpose of the Study:
- To assess the in vitro antiviral effects of Novaferon against SARS-CoV-2.
- To evaluate the clinical efficacy of Novaferon in treating COVID-19 patients.
- To compare Novaferon's effectiveness with Lopinavir/Ritonavir.
Main Methods:
- In vitro experiments determined Novaferon's inhibition of viral replication and entry.
- A randomized, open-label trial enrolled 89 COVID-19 patients.
- Patients received Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir.
Main Results:
- Novaferon inhibited SARS-CoV-2 replication (EC50=1.02ng/ml) and entry (EC50=0.10ng/ml) in vitro.
- Significantly higher viral clearance rates on day six were observed in Novaferon groups compared to Lopinavir/Ritonavir alone (50.0% and 60.0% vs. 24.1%).
- Median time to viral clearance was reduced by 3 days in Novaferon-treated groups (6 days) versus Lopinavir/Ritonavir (9 days).
Conclusions:
- Novaferon exhibits significant anti-SARS-CoV-2 activity both in vitro and in clinical settings.
- Novaferon treatment led to accelerated viral clearance in COVID-19 patients.
- Further clinical evaluation of Novaferon for COVID-19 treatment is warranted.
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