Moderate to Severe COVID-19Phase 3NCT05279235
Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
A Phase 3 study testing JT001 and Favipiravir in people with Moderate to Severe COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe COVID-19
- What is being tested?
- JT001 and Favipiravir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Mar 2022to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of 18 years of age or older, at the time of signing of informed consent
- Participants who have a positive SARS-CoV-2 test result
- Participants who have one or more COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
- Participants who must agree to adhere to contraception restrictions
- Participants who understand and agree to comply with planned study procedures
- Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
- Participants who are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
- Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
- Participants who have any of the following conditions when screening:
- ALT or AST>1.5 ULN
Show all 19Show fewer
- Systolic blood pressure < 90 mm Hg
- Diastolic blood pressure < 60 mm Hg
- Requiring vasopressors
- Multi-organ dysfunction/failure
- Participants who have known allergies to any of the components used in the formulation of the interventions
- Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
- Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
- Participants who have received convalescent COVID-19 plasma treatment
- Participants who have received SARS-CoV-2 vaccine prior to randomization.
- Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
- Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Female who is pregnant or breast-feeding or plan to be pregnant within this study period
- Male whose wife or partner plan to be pregnant within this study period
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Uzbekistan1 site
Specialized lnfectious Diseases Hospital No2 of Zangiota District
Tashkent, Tashkent Region, 1118
About this study
Official title: A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.
Read the detailed description
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment Period
This is the general sequence of events during the 29-day treatment and assessment period:
- Complete baseline procedures and sample collection
- Participants are randomized to an intervention group
- Participants receive study intervention (Q12H X 5 days), and
- Complete all safety monitoring.
- Blood samples collection
- Conditions
- Moderate to Severe COVID-19
- Being tested
- JT001, JT001 placebo, Favipiravir, Favipiravir placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JT001Drug
Also called VV116
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
JT001 placeboDrug
Also called VV116 placebo
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
FavipiravirDrug
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
Favipiravir placeboDrug
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
| Study group | Role | What they receive |
|---|---|---|
| JT001& Favipiravir Placebo | Experimental | JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days Receives: Drug: JT001; Drug: Favipiravir placebo |
| Favipiravir & JT001 Placebo | Active comparator | Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days Receives: Drug: JT001 placebo; Drug: Favipiravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of COVID-19
Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19* or death from any cause, through Day 29
Measured: Up to 29 days
Secondary outcomes (5)
AEs and SAEs
Safety assessments such as AEs and SAEs through Day 29
Measured: Up to 29 days
Progress, Death
Percentage of participants who experience these events by Day 29
- Progress to critical COVID-19
- Death from any cause
Measured: Up to 29 days
WHO 11-point ordinal outcome scale
The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
Measured: Day 3, 5, 7, 10 and 29
The change of Chest CT scan
The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）
Measured: Day 7 and 10
SARS-CoV-2 clearance
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Measured: Day 3, 5 ,7 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Mar 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: Development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe COVID-19Studies 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
- Model description
- Parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Juan Ma, Master, Study director, Shanghai Junshi Bioscience Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279235
- Sponsor's protocol ID
- JT001-006-III-COVID-19
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT05279235
- Acronym / sponsor ID
- JT001-006-III-COVID-19
- Conditions
- Moderate to Severe COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development strategy adjustment
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 15 Mar 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.
Detailed description
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment Period
This is the general sequence of events during the 29-day treatment and assessment period:
- Complete baseline procedures and sample collection
- Participants are randomized to an intervention group
- Participants receive study intervention (Q12H X 5 days), and
- Complete all safety monitoring.
- Blood samples collection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| JT001& Favipiravir Placebo | Experimental | Drug: JT001, Drug: Favipiravir placeboJT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days |
| Favipiravir & JT001 Placebo | Active comparator | Drug: JT001 placebo, Drug: FavipiravirFavipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants of 18 years of age or older, at the time of signing of informed consent
- Participants who have a positive SARS-CoV-2 test result
- Participants who have one or more COVID-19 symptoms, such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath with exertion
- Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
- Participants who must agree to adhere to contraception restrictions
Key exclusion criteria (19 listed)
- Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
- Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
- Participants who are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
- Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
- Participants who have any of the following conditions when screening:
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 |
|---|---|---|
| JT001Also: VV116Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days | Drug | JT001& Favipiravir Placebo |
| JT001 placeboAlso: VV116 placeboDay 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days | Drug | Favipiravir & JT001 Placebo |
| FavipiravirDay 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days | Drug | Favipiravir & JT001 Placebo |
| Favipiravir placeboDay 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days | Drug | JT001& Favipiravir Placebo |
Primary outcome
progression of COVID-19
Time frame: Up to 29 days
Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19* or death from any cause, through Day 29
5 secondary outcomes
AEs and SAEs
Time frame: Up to 29 days
Progress, Death
Time frame: Up to 29 days
WHO 11-point ordinal outcome scale
Time frame: Day 3, 5, 7, 10 and 29
The change of Chest CT scan
Time frame: Day 7 and 10
SARS-CoV-2 clearance
Time frame: Day 3, 5 ,7 and 10
Results and safety
The study was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided. Undecided
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.
Juan Ma, Master study director
Shanghai Junshi Bioscience Co., Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JT001 and Favipiravir in people with Moderate to Severe COVID-19, run by Shanghai Vinnerna Biosciences Co., Ltd. at 2 sites in 2 countries.
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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Uzbekistan. 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. 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?
The study was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of COVID-19 (time frame: Up to 29 days). 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 8 Feb 2023.