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 = 1.02 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/).
【저자키워드】 COVID-19, SARS-CoV-2, Lopinavir/ritonavir, viral clearance, antiviral drug, Novaferon, Aerosolized inhalation, 【초록키워드】 Treatment, viral infection, Trial, Open-label, Antiviral, in vitro, anti-SARS-CoV-2, Antiviral effect, Laboratory, Randomized, Protein, viral replication, clinical, registry, group, COVID-19 patients, clearance rate, primary endpoint, COVID-19 patient, number, secondary endpoint, median time, SARS-CoV-2 entry, Chinese, viral clearance rate, three groups, parallel-group, SARS-CoV-2 clearance, EC50, Effect, Cell, Result, enrolled, healthy, evaluated, inhibited, nine, exhibited, was determined, significantly higher, prevented, reduction in, infected with SARS-CoV-2, the SARS-CoV-2, 【제목키워드】 Trial, Open-label, Randomized, COVID-19 patient, parallel-group, SARS-CoV-2 clearance,