This is a phase III randomized, double blinded, placebo-controlled multi-center study toassess the efficacy and safety of aerosolized Novaferon for the treatment of asymptomaticor mildly patients infected with SARS-CoV-2.
Since the outbreak of New Coronavirus pneumonia (COVID-19) in late 2019, epidemics around
the world are still developing. There are about 200 million confirmed cases in the world,
including about 4.26 million deaths until August 5, 2021, which has become a major
disaster for human being.
Most of SARS-CoV-2 infection are asymptomatic or mild cases, which is the main factor
causing viral transmission. Although COVID-19 patients have immune protection after cured
or vaccinated, there still be a percentage of people vaccinated who still get sick,
hospitalized, or die caused by COVID-19. COVID-19 vaccine breakthrough and reinfection
cases became one of key problems for COVID-19 prevention and control. In addition,
SARS-CoV-2 variants circulated in the world. However, some variants were associated with
disease severity, the performance of vaccines, therapeutic medicines, diagnostic tools,
or other public health and social measures. Variants (e.g., Delta variant) caused some
vaccine breakthrough cases. There is an urgent need for effective antiviral drugs.
Novaferon is a marketed antiviral drug in China and proved to have more than ten-fold
antiviral potency than that of similar interferon α-2b. Novaferon exerts antiviral
activity by three ways: blocking virus entry into cells, inducing expression of antiviral
genes and proteins (e.g., MX1 and OAS), and promoting apoptosis of infected cells. In
vitro experimental study showed Novaferon exhibited anti-SARS-CoV-2 effects at the
cellular level. A randomized, open-label, parallel-group trial demonstrated that
aerosolized Novaferon expedited clearance and negative conversion of SARS-CoV-2, which
provide the rational for large-scale clinical studies to verify the efficacy of Novaferon
as a potential antiviral drug for COVID-19. Inhalation administration has advantages over
systemic administration in reducing adverse drug reactions, promoting the distribution of
drugs in respiratory tract, and thus enhancing the mucosal immunity.
This is a phase III randomized, double blinded, placebo-controlled multi-center study to
assess the efficacy, and safety of aerosolized Novaferon for the treatment of
asymptomatic patients or patients with mild COVID-19.
Drug: Recombinant cytokine gene derived protein injection
Aerosolized Novaferon, given 20 ug BID, daily for 7 days, plus Standard of Care.
Inhaled Saline (placebo), given BID, daily for 7 days, plus Standard of Care.
Other Name: Saline
Inclusion Criteria:1.Patient capable of giving consent, or, when the patient is not
capable of giving consent, by his or her legal/authorized representatives prior to
initiation of any study procedures.
2.Male or female, between 18 and 65 years of age at the time of consent.
3.Laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in nasopharyngeal or
oropharyngeal swabs < 72 hours prior to enrollment.
4Patients with asymptomatics or mild COVID-19, including:
1. Patients with asymptomatic infections refer to those with positive testing results
in etiological detection of SARS-CoV-2 in swabs, but without any relevant clinical
manifestations, such as self-perceived or clinically identified symptoms or signs,
including fever, cough and sore throat, and without any typical imaging features of
COVID-19 in their CT scans.
2. Patients with mild SARS-COV-2 infections refer to those who are infected with
SARS-COV-2 presenting mild symptoms in accordance with Diagnosis and Treatment
Protocol for Novel Coronavirus Pneumonia (Trial Revision 8): mild clinical symptoms,
and no findings of pneumonia in chest CT images.
- Exclusion Criteria:1.Patients classified into Moderate, Severe, and Critical cases
according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial
8th Edition) 2.Females who are breast-feeding, lactating, pregnant or intending to become
pregnant 3.Patients who are receiving any treatment with interferon or participating in
other clinical studies of antiviral therapy.
4.Patients who are unable to collaborate due to poor mental health, suffering from
psychiatric illness, or incapable of controlling themselves or expressing clearly.
5.Patients excluded in the opinion of the investigators.
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