Novaferon in Non-hospitalized Adult Patients With Mild COVID-19

Last updated: February 15, 2022
Sponsor: Genova Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05172037
JH-COR-007
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 drugadministration.
  3. Less than six days from onset of COVID-19-related symptoms below to starting theadministration of the investigational drug with at least one of the following symptomsobserved 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 otherCOVID-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 negativepregnancy test (urine hCG qualification) and agree to use highly effectivecontraceptive methods (taking oral contraceptives or use of condom by male partner)during the study period. Investigators or coinvestigators investigators will provideguidance on contraceptive methods.
  7. Women who are not breast-feeding.

Exclusion

Exclusion Criteria:

  1. History of hypersensitivity to interferon or JH509 or any excipients of interferon orJH509.
  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 thepast or having had it considered necessary to receive these treatments during thestudy period.
  3. Having had it considered necessary to receive treatments, such as drugs containingcorticosteroids (excluding topical drugs), antimicrobial agents, and inhalants otherthan 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 1year before consent acquisition.
  9. Inappropriate for inclusion in the clinical trial as determined by investigators orcoinvestigators investigators.

Study Design

Total Participants: 222
Study Start date:
October 28, 2021
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Tokyo Shinagawa Hospital

    Tokyo,
    Japan

    Active - Recruiting

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