Covid19Phase 3NCT04708158
Novaferon for COVID-19 Treatment Trial (NCTT-005)
A Phase 3 study testing Novaferon in people with Covid19, run by Genova Inc. at 22 sites in Japan.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Novaferon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 22 sitesJapan
- Study dates
- 25 Mar 2021to 30 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
Haifeng Jin contact
22 sites in 1 country
Japan22 sites, 15 recruiting
- Recruiting
Chiba Aoba Municipal Hospital
Chiba
Yasuo Takiguchi, 043-227-1131
- Recruiting
Kamagaya General Hospital
Chiba
Takaki Hori, 047-4988-8111
- Recruiting
NHO Chiba Medical Center
Chiba
043-251-5311
- Active, not recruiting
NHO Omuta National Hospital
Fukuoka
- Recruiting
NHO Kasumigaura Medical Center
Ibaraki
Norihiro Kikuchi, 029-822-5050
- Active, not recruiting
Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital
Ibaraki
- Recruiting
Kokankai Nippon Kokan Hospital
Kanagawa
Naoki Miyao, 044-333-5591
- Recruiting
Rakuwakai Otowa Hospital
Kyoto
Haruki Imura, 075-593-4111
- Recruiting
Okayama City General Medical Center Okayama City Hospital
Okayama
Yu Suganami, 086-737-3000
- Recruiting
Osaka Habikino Medical Center
Osaka
Shoji Hashimoto, +81729572121
- Recruiting
Rinku General Medical Center
Osaka
Masaya Yamato, 072-469-3111
- Recruiting
Sakai City Medical Center
Osaka
Koji Nishida, 072-272-1199
- Recruiting
Omi Medical Center
Shiga
Katsunori Tai, 077-563-8866
- Active, not recruiting
NHO Utsunomiya Hospital
Tochigi
- Active, not recruiting
Japanese Red Cross Medical Center
Tokyo
- Active, not recruiting
Juntendo University Hospital
Tokyo
- Active, not recruiting
Nihon University Itabashi Hospital
Tokyo
- Active, not recruiting
Showa University East Hospital
Tokyo
- Recruiting
Showa University Hospital
Tokyo
Hironori Sagare, 03-3784-8000
- Recruiting
Tokyo Medical University Hachioji Medical Center
Tokyo
Yuji Hirai, 042-665-5611
- Recruiting
Tokyo Shinagawa Hospital
Tokyo
Masaharu Shinkai, +81337640511
- Recruiting
NHO Iwakuni Clinical Center
Yamaguchi
Shoichi Kuyama, 0827-34-1000
About this study
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
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
- Conditions
- Covid19
- Being tested
- Novaferon, Placebo
- Keywords
- antiviral, SARS-CoV-2, COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaferonBiological
a novel recombinant antiviral protein drug
PlaceboBiological
Saline
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Inhaled Novaferon, given 20 ug BID, daily for 7 days Receives: Biological: Novaferon |
| Placebo | Placebo comparator | Inhaled saline (placebo), given BID, daily for 7 days Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
Measured: From enrollment up to Day 28
Secondary outcomes (12)
Rate of clinical improvement
Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Each Day from Day 1 up to Day 28
Mortality rate
Mortality rate
Measured: At Day 28
Duration of hospital stay
Number of days the patient is in hospital
Measured: 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
Measured: From enrollment up to Day 28
Requirement of supplemental oxygen
Rate at which patients require supplemental oxygen
Measured: From enrollment up to Day 28
Requirement of mechanical ventilation
Rate at which patients require mechanical ventilation (invasive or non-invasive)
Measured: From enrollment up to Day 28
Rate of alive patients
Rate of patients alive without having to use invasive ventilator or ECMO
Measured: At Day 28
Adverse events
Adverse event incidence, type and severity
Measured: From enrollment up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start25 Mar 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genova Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708158
- Sponsor's protocol ID
- JH-COR-005
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04708158
- Acronym / sponsor ID
- JH-COR-005
- Conditions
- Covid19
- Keywords
- antiviral, SARS-CoV-2, COVID19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Genova Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: NovaferonInhaled Novaferon, given 20 ug BID, daily for 7 days |
| Placebo | Placebo comparator | Biological: PlaceboInhaled saline (placebo), given BID, daily for 7 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novaferona novel recombinant antiviral protein drug | Biological | Active |
| PlaceboSaline | Biological | Placebo |
Primary outcome
Time to clinical improvement
Time frame: From enrollment up to Day 28
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
12 secondary outcomes
Rate of clinical improvement
Time frame: Day 1 to Day 10, 14 and 28
Rate of clinical deterioration
Time frame: Day 1 to Day 10, 14 and 28
Time to viral clearance
Time frame: From enrollment up to Day 28
Rate of viral clearance
Time frame: Each Day from Day 1 up to Day 28
Change in viral load
Time frame: Each Day from Day 1 up to Day 28
Mortality rate
Time frame: At Day 28
Duration of hospital stay
Time frame: From enrollment up to Day 28
Time to resolution of symptoms
Time frame: From enrollment up to Day 28
Requirement of supplemental oxygen
Time frame: From enrollment up to Day 28
Requirement of mechanical ventilation
Time frame: From enrollment up to Day 28
Rate of alive patients
Time frame: At Day 28
Adverse events
Time frame: From enrollment up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haifeng Jin contact
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Novaferon in people with Covid19, run by Genova Inc. at 22 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huimei Huang (+6582027938, hhuang@genova.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: From enrollment up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.