Back to resultsNovaferon for COVID-19 Treatment Trial (NCTT-005)
Primary Purpose
Covid19
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Novaferon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring antiviral, SARS-CoV-2, COVID19
Eligibility Criteria
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.
Sites / Locations
- Chiba Aoba Municipal HospitalRecruiting
- Kamagaya General HospitalRecruiting
- NHO Chiba Medical CenterRecruiting
- NHO Omuta National Hospital
- NHO Kasumigaura Medical CenterRecruiting
- Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
- Kokankai Nippon Kokan HospitalRecruiting
- Rakuwakai Otowa HospitalRecruiting
- Okayama City General Medical Center Okayama City HospitalRecruiting
- Osaka Habikino Medical CenterRecruiting
- Rinku General Medical CenterRecruiting
- Sakai City Medical CenterRecruiting
- Omi Medical CenterRecruiting
- NHO Utsunomiya Hospital
- Japanese Red Cross Medical Center
- Juntendo University Hospital
- Nihon University Itabashi Hospital
- Showa University East Hospital
- Showa University HospitalRecruiting
- Tokyo Medical University Hachioji Medical CenterRecruiting
- Tokyo Shinagawa HospitalRecruiting
- NHO Iwakuni Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Inhaled Novaferon, given 20 ug BID, daily for 7 days
Inhaled saline (placebo), given BID, daily for 7 days
Outcomes
Primary Outcome Measures
Time to clinical improvement
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
Secondary Outcome Measures
Rate of clinical improvement
Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale
Rate of clinical deterioration
Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale
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
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
Change in viral load
Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs
Mortality rate
Mortality rate
Duration of hospital stay
Number of days the patient is in hospital
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
Requirement of supplemental oxygen
Rate at which patients require supplemental oxygen
Requirement of mechanical ventilation
Rate at which patients require mechanical ventilation (invasive or non-invasive)
Rate of alive patients
Rate of patients alive without having to use invasive ventilator or ECMO
Adverse events
Adverse event incidence, type and severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04708158
Brief Title
Novaferon for COVID-19 Treatment Trial (NCTT-005)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genova Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
antiviral, SARS-CoV-2, COVID19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
385 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Inhaled Novaferon, given 20 ug BID, daily for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inhaled saline (placebo), given BID, daily for 7 days
Intervention Type
Biological
Intervention Name(s)
Novaferon
Intervention Description
a novel recombinant antiviral protein drug
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Time to clinical improvement
Description
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
Time Frame
From enrollment up to Day 28
Secondary Outcome Measure Information:
Title
Rate of clinical improvement
Description
Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale
Time Frame
Day 1 to Day 10, 14 and 28
Title
Rate of clinical deterioration
Description
Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale
Time Frame
Day 1 to Day 10, 14 and 28
Title
Time to viral clearance
Description
Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs
Time Frame
From enrollment up to Day 28
Title
Rate of viral clearance
Description
The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs
Time Frame
Each Day from Day 1 up to Day 28
Title
Change in viral load
Description
Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs
Time Frame
Each Day from Day 1 up to Day 28
Title
Mortality rate
Description
Mortality rate
Time Frame
At Day 28
Title
Duration of hospital stay
Description
Number of days the patient is in hospital
Time Frame
From enrollment up to Day 28
Title
Time to resolution of symptoms
Description
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
Time Frame
From enrollment up to Day 28
Title
Requirement of supplemental oxygen
Description
Rate at which patients require supplemental oxygen
Time Frame
From enrollment up to Day 28
Title
Requirement of mechanical ventilation
Description
Rate at which patients require mechanical ventilation (invasive or non-invasive)
Time Frame
From enrollment up to Day 28
Title
Rate of alive patients
Description
Rate of patients alive without having to use invasive ventilator or ECMO
Time Frame
At Day 28
Title
Adverse events
Description
Adverse event incidence, type and severity
Time Frame
From enrollment up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huimei Huang
Phone
+6582027938
Email
hhuang@genova.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng Jin
Email
kkin@genova.cn
Facility Information:
Facility Name
Chiba Aoba Municipal Hospital
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuo Takiguchi
Phone
043-227-1131
Facility Name
Kamagaya General Hospital
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takaki Hori
Phone
047-4988-8111
Facility Name
NHO Chiba Medical Center
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
043-251-5311
Facility Name
NHO Omuta National Hospital
City
Fukuoka
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
NHO Kasumigaura Medical Center
City
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norihiro Kikuchi
Phone
029-822-5050
Facility Name
Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
City
Ibaraki
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kokankai Nippon Kokan Hospital
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoki Miyao
Phone
044-333-5591
Facility Name
Rakuwakai Otowa Hospital
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haruki Imura
Phone
075-593-4111
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Suganami
Phone
086-737-3000
Facility Name
Osaka Habikino Medical Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoji Hashimoto
Phone
+81729572121
Facility Name
Rinku General Medical Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaya Yamato
Phone
072-469-3111
Facility Name
Sakai City Medical Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Nishida
Phone
072-272-1199
Facility Name
Omi Medical Center
City
Shiga
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsunori Tai
Phone
077-563-8866
Facility Name
NHO Utsunomiya Hospital
City
Tochigi
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Japanese Red Cross Medical Center
City
Tokyo
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Juntendo University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nihon University Itabashi Hospital
City
Tokyo
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Showa University East Hospital
City
Tokyo
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Showa University Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hironori Sagare
Phone
03-3784-8000
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Hirai
Phone
042-665-5611
Facility Name
Tokyo Shinagawa Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaharu Shinkai
Phone
+81337640511
Facility Name
NHO Iwakuni Clinical Center
City
Yamaguchi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoichi Kuyama
Phone
0827-34-1000
12. IPD Sharing Statement
Learn more about this trial
Novaferon for COVID-19 Treatment Trial (NCTT-005)
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