Novaferon for COVID-19 Treatment Trial (NCTT-005)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Aerosolized Novaferon vs. Placebo in Hospitalized Adult Patients With ModerateCOVID-19

A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 385
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Huimei Huang; Phone Number: +6582027938; Email: hhuang@genova.cn
• Study Contact Backup: Name: Haifeng Jin; Email: kkin@genova.cn

Study Locations

• Japan
  • Chiba, Japan
    • Recruiting
    • Chiba Aoba Municipal Hospital
    • Contact: Yasuo Takiguchi; Phone Number: 043-227-1131
  • Chiba, Japan
    • Recruiting
    • Kamagaya General Hospital
    • Contact: Takaki Hori; Phone Number: 047-4988-8111
  • Chiba, Japan
    • Recruiting
    • NHO Chiba Medical Center
    • Contact: Phone Number: 043-251-5311
  • Fukuoka, Japan
    • Active, not recruiting
    • NHO Omuta National Hospital
  • Ibaraki, Japan
    • Recruiting
    • NHO Kasumigaura Medical Center
    • Contact: Norihiro Kikuchi; Phone Number: 029-822-5050
  • Ibaraki, Japan
    • Active, not recruiting
    • Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
  • Kanagawa, Japan
    • Recruiting
    • Kokankai Nippon Kokan Hospital
    • Contact: Naoki Miyao; Phone Number: 044-333-5591
  • Kyoto, Japan
    • Recruiting
    • Rakuwakai Otowa Hospital
    • Contact: Haruki Imura; Phone Number: 075-593-4111
  • Okayama, Japan
    • Recruiting
    • Okayama City General Medical Center Okayama City Hospital
    • Contact: Yu Suganami; Phone Number: 086-737-3000
  • Osaka, Japan
    • Recruiting
    • Osaka Habikino Medical Center
    • Contact: Shoji Hashimoto; Phone Number: +81729572121
  • Osaka, Japan
    • Recruiting
    • Rinku General Medical Center
    • Contact: Masaya Yamato; Phone Number: 072-469-3111
  • Osaka, Japan
    • Recruiting
    • Sakai City Medical Center
    • Contact: Koji Nishida; Phone Number: 072-272-1199
  • Shiga, Japan
    • Recruiting
    • Omi Medical Center
    • Contact: Katsunori Tai; Phone Number: 077-563-8866
  • Tochigi, Japan
    • Active, not recruiting
    • NHO Utsunomiya Hospital
  • Tokyo, Japan
    • Active, not recruiting
    • Japanese Red Cross Medical Center
  • Tokyo, Japan
    • Active, not recruiting
    • Juntendo University Hospital
  • Tokyo, Japan
    • Active, not recruiting
    • Nihon University Itabashi Hospital
  • Tokyo, Japan
    • Active, not recruiting
    • Showa University East Hospital
  • Tokyo, Japan
    • Recruiting
    • Showa University Hospital
    • Contact: Hironori Sagare; Phone Number: 03-3784-8000
  • Tokyo, Japan
    • Recruiting
    • Tokyo Medical University Hachioji Medical Center
    • Contact: Yuji Hirai; Phone Number: 042-665-5611
  • Tokyo, Japan
    • Recruiting
    • Tokyo Shinagawa Hospital
    • Contact: Masaharu Shinkai; Phone Number: +81337640511
  • Yamaguchi, Japan
    • Recruiting
    • NHO Iwakuni Clinical Center
    • Contact: Shoichi Kuyama; Phone Number: 0827-34-1000

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:

• Written informed consent has been obtained from the participants with age of over 20 years at the time of signing the informed consent.
• SARS-CoV-2 infection is diagnosed by the positive SARS-CoV-2 detection of RT-PCR tests within 72 hours before the start of administration of the investigational drug
• Less than 6 days from onset of COVID-19 symptoms to starting the administration of the investigational drug. The symptoms are defined as one or more of the following: fever (37.5 ºC or higher), respiratory symptoms (cough, shortness of breath, chest pain, sore throat, running nose, nasal congestion, etc.), headache, malaise, abdominal pain, diarrhea, nausea, vomiting, loss of smell, loss of taste, or other COVID-19 symptoms defined by investigators or physicians.
• Have at least one of the following findings.
• Oxygen saturation (SpO2) measured by pulse oximeter is less than 96% and more than 93%.
• Chest X-ray or CT scan shows pneumonia findings suggestive of COVID-19 infection
• Need hospitalization and COVID-19-related medical care.
• 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 take oral contraceptives or use condom during study period.

Exclusion Criteria:

• History of hypersensitivity to interferon or Novaferon or any excipients of interferon or Novaferon.
• Having received other antiviral treatments (Favipiravir, Remdesivir, Interferon, etc.).
• 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.
• Inappropriate for inclusion in the clinical trial as determined by 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
Experimental: Active; Inhaled Novaferon, given 20 ug BID, daily for 7 days	Biological: Novaferon; a novel recombinant antiviral protein drug
Placebo Comparator: Placebo; Inhaled saline (placebo), given BID, daily for 7 days	Biological: Placebo; Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical improvement	Time to patient clinical improvement by 2 points on a 7-point ordinal scale	From enrollment up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical improvement	Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale	Day 1 to Day 10, 14 and 28
Rate of clinical deterioration	Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale	Day 1 to Day 10, 14 and 28
Time to viral clearance	Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs	From enrollment up to Day 28
Rate of viral clearance	The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs	Each Day from Day 1 up to Day 28
Change in viral load	Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs	Each Day from Day 1 up to Day 28
Mortality rate	Mortality rate	At Day 28
Duration of hospital stay	Number of days the patient is in hospital	From enrollment up to Day 28
Time to resolution of symptoms	Time taken for patients to demonstrate a resolution of symptoms defined as a (National Early Warning Score 2) NEWS 2 of 0 maintained for 24hours	From enrollment up to Day 28
Requirement of supplemental oxygen	Rate at which patients require supplemental oxygen	From enrollment up to Day 28
Requirement of mechanical ventilation	Rate at which patients require mechanical ventilation (invasive or non-invasive)	From enrollment up to Day 28
Rate of alive patients	Rate of patients alive without having to use invasive ventilator or ECMO	At Day 28
Adverse events	Adverse event incidence, type and severity	From enrollment up to Day 28

Collaborators and Investigators

• Sponsor: Genova Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: December 1, 2021

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-005

Drug and device information, study documents

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