Novaferon in Non-hospitalized Adult Patients With Mild COVID-19
NCT ID: NCT05172037
Last Updated: 2022-03-03
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
222 participants
INTERVENTIONAL
2021-10-28
2022-06-30
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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Novaferon
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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Placebo
Saline
Novaferon
a novel recombinant antiviral protein drug
Eligibility Criteria
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Inclusion Criteria
2. SARS-CoV-2 infection is diagnosed by RT-PCR within 72 hours before starting drug administration.
3. Less than six days from onset of COVID-19-related symptoms below to starting the administration of the investigational drug with at least one of the following symptoms observed at the time of enrollment : fever (37.5C or higher), respiratory symptoms (cough, shortness of breath, sore throat, runny nose, etc.), headache, myalgia, malaise, abdominal pain, diarrhea, nausea/vomiting, dysosmia, dysgeusia, or other COVID-19 symptoms defined by investigators or coinvestigators investigators.
4. Oxygen saturation (SpO2) measured by pulse oximeter is more than 95%.
5. Require no supplemental oxygen.
6. Women (less than 12 months after the last menstrual period) who have a negative pregnancy test (urine hCG qualification) and agree to use highly effective contraceptive methods (taking oral contraceptives or use of condom by male partner) during the study period. Investigators or coinvestigators investigators will provide guidance on contraceptive methods.
7. Women who are not breast-feeding.
Exclusion Criteria
2. Have received antiviral treatments and drugs expected to have antiviral effects (Favipiravir, Remdesivir, Interferon, Nafamostat mesilate, and Basiliximab/Imdevimab, including drugs that are being newly developed and that have been approved) in the past or having had it considered necessary to receive these treatments during the study period.
3. Having had it considered necessary to receive treatments, such as drugs containing corticosteroids (excluding topical drugs), antimicrobial agents, and inhalants other than the investigational drug during the study period.
4. Taking "Shosaikoto," an herbal medicine.
5. Neuropsychiatric disorder and autoimmune disorder.
6. CTCAE Grade 3 or higher liver dysfunction (ALT/AST \> 5ULN) or renal dysfunction (eGFR \< 30 mL/min/1.73 m2).
7. Active infections or other medical conditions that contraindicate inhalation therapy.
8. Having the complication of malignant tumor or a history of malignant tumor within 1 year before consent acquisition.
9. Inappropriate for inclusion in the clinical trial as determined by investigators or coinvestigators investigators.
20 Years
ALL
No
Sponsors
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Tokyo Shinagawa Hospital
OTHER
Genova Inc.
INDUSTRY
Responsible Party
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Locations
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Tokyo Shinagawa Hospital
Tokyo, , Japan
Countries
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Central Contacts
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Haifeng Jin
Role: CONTACT
Facility Contacts
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Masaharu Shinkai
Role: primary
Other Identifiers
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JH-COR-007
Identifier Type: -
Identifier Source: org_study_id
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