Covid19Phase 3NCT05172037
Novaferon in Non-hospitalized Adult Patients With Mild COVID-19
A Phase 3 study testing Novaferon in people with Covid19, run by Genova Inc. at 1 site in Japan.
Trial 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 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
- 222 participants
- Where
- 1 siteJapan
- Study dates
- 28 Oct 2021to Jun 2022
- 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 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.
Who cannot join
- 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).
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- 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.
- Inappropriate for inclusion in the clinical trial as determined by investigators or coinvestigators investigators.
Trial locations and contacts
1 site in 1 country.
Haifeng Jin contact
Japan1 site, 1 recruiting
- Recruiting
Tokyo Shinagawa Hospital
Tokyo
Masaharu Shinkai, +81337640511
About this study
Official title: 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
- 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 |
|---|---|---|
| Novaferon | Active comparator | 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.
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.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start28 Oct 2021
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genova Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tokyo Shinagawa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172037
- Sponsor's protocol ID
- JH-COR-007
- Status last verified
- Feb 2022
- First submitted
- 26 Dec 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05172037
- Acronym / sponsor ID
- JH-COR-007
- Conditions
- Covid19
- Keywords
- antiviral, SARS-CoV-2, COVID19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Genova Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tokyo Shinagawa Hospital
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 Dec 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novaferon | Active comparator | 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 (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 | Novaferon |
| PlaceboSaline | Biological | Placebo |
Primary outcome
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.
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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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
1 site 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 1 site 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 7 inclusion and 9 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Masaharu Shinkai (+81337640511, shikai050169@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 28 day). 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 3 Mar 2022.