A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Biological: Novaferon
a novel recombinant antiviral protein drug
Biological: Placebo
Saline
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.
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
Huimei Huang
+6582027938
hhuang@genova.cn
Haifeng Jin
kkin@genova.cn