Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
385 participants
INTERVENTIONAL
2021-03-25
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
Inhaled Novaferon, given 20 ug BID, daily for 7 days
Novaferon
a novel recombinant antiviral protein drug
Placebo
Inhaled saline (placebo), given BID, daily for 7 days
Placebo
Saline
Interventions
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Novaferon
a novel recombinant antiviral protein drug
Placebo
Saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Genova Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yasuo Takiguchi
Role: primary
Takaki Hori
Role: primary
Role: primary
Norihiro Kikuchi
Role: primary
Naoki Miyao
Role: primary
Haruki Imura
Role: primary
Yu Suganami
Role: primary
Shoji Hashimoto
Role: primary
Masaya Yamato
Role: primary
Koji Nishida
Role: primary
Katsunori Tai
Role: primary
Hironori Sagare
Role: primary
Yuji Hirai
Role: primary
Masaharu Shinkai
Role: primary
Shoichi Kuyama
Role: primary
Other Identifiers
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JH-COR-005
Identifier Type: -
Identifier Source: org_study_id
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