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SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial
- Source :
- International Journal of Infectious Diseases, Vol 99, Iss, Pp 84-91 (2020), International Journal of Infectious Diseases, International journal of infectious diseases, 99:84-91
- Publication Year :
- 2020
- Publisher :
- Elsevier, 2020.
-
Abstract
- Highlights • Novaferon considered as a potential antiviral drug for COVID-19. • Novaferon inhibited viral replication and protected cells from SARS-CoV-2 attack. • Antiviral effects of Novaferon for COVID-19 patients observed in randomized trial. • Inhalation of Novaferon for COVID-19 treatment was safe.<br />Background The anti-viral effects of Novaferon, a potent antiviral protein drug on COVID-19 was evaluated in laboratory, and in a randomized, open-label, parallel group trial. Methods In laboratory, the inhibition of Novaferon on viral replication in cells infected with SARS-CoV-2, and on 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 6 of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance. Results Novaferon inhibited the 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 6than Lopinavir/Ritonavir group (50.0% vs.24.1%, p = 0.0400, and 60.0% vs.24.1%, p = 0.0053). Median time to viral clearance were 6 days, 6 days, and 9 days for three groups respectively, a 3-dayreductionin both Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with Lopinavir/Ritonavir group. Conclusions Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justified the further evaluation of Novaferon. Trial registration number number ChiCTR2000029496at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).
- Subjects :
- 0301 basic medicine
Drug
Microbiology (medical)
medicine.medical_specialty
media_common.quotation_subject
viruses
030106 microbiology
Antiviral protein
Viral clearance
Gastroenterology
Article
lcsh:Infectious and parasitic diseases
03 medical and health sciences
0302 clinical medicine
immune system diseases
Internal medicine
Clinical endpoint
Medicine
lcsh:RC109-216
030212 general & internal medicine
media_common
Novaferon
COVID-19
Aerosolized inhalation
Antiviral drug
Lopinavir/Ritonavir
SARS-CoV-2
business.industry
virus diseases
Lopinavir
General Medicine
Clinical trial
Infectious Diseases
Viral replication
Ritonavir
business
Clearance rate
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 12019712 and 20000294
- Volume :
- 99
- Database :
- OpenAIRE
- Journal :
- International Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....d8b45f8d11c316b4c6a0e0766d0761bc