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

NCT05172037 | Unknown Phase 3

• 1 other identifier: JH-COR-007
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Covid19

Keywords

antiviral; SARS-CoV-2; COVID19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Novaferon

ACTIVE COMPARATOR

Inhaled Novaferon, given 20 ug BID, daily for 7 days

Biological: Novaferon

Placebo

PLACEBO COMPARATOR

Inhaled saline (placebo), given BID, daily for 7 days

Biological: Placebo

Interventions

Novaferon BIOLOGICAL

a novel recombinant antiviral protein drug

Novaferon

Placebo BIOLOGICAL

Saline

Placebo

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent has been obtained from the participants with an age of over 20 years at the time of signing the informed consent.
• SARS-CoV-2 infection is diagnosed by RT-PCR within 72 hours before starting drug administration.
• 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.
• Oxygen saturation (SpO2) measured by pulse oximeter is more than 95%.
• 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 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.
• Women who are not breast-feeding.

You may not qualify if:

• History of hypersensitivity to interferon or JH509 or any excipients of interferon or JH509.
• 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.
• 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.
• Taking "Shosaikoto," an herbal medicine.
• Neuropsychiatric disorder and autoimmune disorder.
• 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.
• Having the complication of malignant tumor or a history of malignant tumor within 1 year before consent acquisition.

Sponsors & Collaborators

• Genova Inc.: lead
• Tokyo Shinagawa Hospital: collaborator

Study Sites (1)

Tokyo Shinagawa Hospital

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

recombinant interferon alpha 2b-like protein

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Masaharu Shinkai

CONTACT

+81337640511; shikai050169@gmail.com

Haifeng Jin

CONTACT

+81366616198

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: December 29, 2021
• Study Start: October 28, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)