SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.
Int J Infect Dis
; 99: 84-91, 2020 Oct.
Article
in English
| MEDLINE | ID: covidwho-692871
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/).Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Interferons
/
Coronavirus Infections
/
Betacoronavirus
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Female
/
Humans
/
Male
Language:
English
Journal:
Int J Infect Dis
Journal subject:
Communicable Diseases
Year:
2020
Document Type:
Article
Affiliation country:
J.ijid.2020.07.053
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