Official Title
An Adaptive, Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Aerosolized JH509 vs. Placebo in Non-hospitalized Adult Patients With Mild COVID-19
Brief Summary

An Adaptive, Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Study toEvaluate the Efficacy and Safety of Aerosolized JH509 vs. Placebo in Non-hospitalizedAdult Patients with Mild COVID-19

Detailed Description

Not Provided

Unknown status
COVID19

Biological: Novaferon

a novel recombinant antiviral protein drug

Biological: Placebo

Saline

Eligibility Criteria

Inclusion Criteria:

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

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:

1. History of hypersensitivity to interferon or JH509 or any excipients of interferon
or JH509.

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.

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

Tokyo Shinagawa Hospital
Tokyo, Japan

Investigator: Masaharu Shinkai
Contact: +81337640511

Contacts

Masaharu Shinkai
+81337640511
shikai050169@gmail.com

Haifeng Jin
+81366616198

Not Provided

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