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

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

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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: Placebo; Biological: Novaferon

• Study Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Masaharu Shinkai; Phone Number: +81337640511; Email: shikai050169@gmail.com
• Study Contact Backup: Name: Haifeng Jin; Phone Number: +81366616198

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Tokyo Shinagawa Hospital
    • Contact: Masaharu Shinkai; Phone Number: +81337640511

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Inhaled saline (placebo), given BID, daily for 7 days	Biological: Placebo; Saline
Active Comparator: Novaferon; Inhaled Novaferon, given 20 ug BID, daily for 7 days	Biological: Novaferon; a novel recombinant antiviral protein drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of severe conditions with Score 3 or more serious on a seven-point ordinal scale from the start date of investigational drug administration (Day 1) to Day 28.	28 day

Collaborators and Investigators

• Sponsor: Genova Inc.
• Collaborators: Tokyo Shinagawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID19; antiviral
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JH-COR-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No