Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon vs. Placebo in Hospitalized Adult Patients With ModerateCOVID-19
Brief Summary

A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients

Recruiting
COVID19

Biological: Novaferon

a novel recombinant antiviral protein drug

Biological: Placebo

Saline

Eligibility Criteria

Inclusion Criteria:

- Written informed consent has been obtained from the participants with age of over 20
years at the time of signing the informed consent.

- SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR tests
within 72 hours before the start of administration of the investigational drug

- Less than 6 days from onset of COVID-19 symptoms to starting the administration of the
investigational drug. The symptoms are defined as one or more of the following: fever
(37.5 ºC or higher), respiratory symptoms (cough, shortness of breath, chest pain,
sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain,
diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms
defined by investigators or physicians.

- Have at least one of the following findings.

- Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% and more than
93%.

- Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection

- Need hospitalization and COVID-19-related medical care.

- Require no supplemental oxygen.

- Women (less than 12 months after the last menstrual period) who have a negative
pregnancy test (urine hCG qualification) and agree to take oral contraceptives or use
condom during study period.

Exclusion Criteria:

- History of hypersensitivity to interferon or Novaferon or any excipients of interferon
or Novaferon.

- Having received other antiviral treatments (Favipiravir, Remdesivir, Interferon,
etc.).

- CTCAE Grade 3 or higher liver dysfunction (ALT / AST> 5ULN) or renal dysfunction (eGFR
<30 mL / min / 1.73 m2).

- Active infections or other medical conditions that contraindicate inhalation therapy.

- Inappropriate for inclusion in the clinical trial as determined by investigators.

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: N/A
Countries
Japan
Locations

Chiba Aoba Municipal Hospital
Chiba, Japan

Kamagaya General Hospital
Chiba, Japan

NHO Chiba Medical Center
Chiba, Japan

NHO Omuta National Hospital
Fukuoka, Japan

NHO Kasumigaura Medical Center
Ibaraki, Japan

Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
Ibaraki, Japan

Kokankai Nippon Kokan Hospital
Kanagawa, Japan

Rakuwakai Otowa Hospital
Kyoto, Japan

Okayama City General Medical Center Okayama City Hospital
Okayama, Japan

Osaka Habikino Medical Center
Osaka, Japan

Rinku General Medical Center
Osaka, Japan

Sakai City Medical Center
Osaka, Japan

Omi Medical Center
Shiga, Japan

NHO Utsunomiya Hospital
Tochigi, Japan

Japanese Red Cross Medical Center
Tokyo, Japan

Juntendo University Hospital
Tokyo, Japan

Nihon University Itabashi Hospital
Tokyo, Japan

Showa University East Hospital
Tokyo, Japan

Showa University Hospital
Tokyo, Japan

Tokyo Medical University Hachioji Medical Center
Tokyo, Japan

Tokyo Shinagawa Hospital
Tokyo, Japan

NHO Iwakuni Clinical Center
Yamaguchi, Japan

Contacts

Huimei Huang
+6582027938
hhuang@genova.cn

Haifeng Jin
kkin@genova.cn

NCT Number
Keywords
Antiviral
SARS-CoV-2
COVID19
MeSH Terms
COVID-19