Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
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Complete baseline procedures and sample collection
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Participants are randomized to an intervention group
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Participants receive study intervention (Q12H X 5 days), and
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Complete all safety monitoring.
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Blood samples collection
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JT001& Favipiravir Placebo 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 |
Drug: JT001
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Other Names:
Drug: Favipiravir placebo
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
|
| Active Comparator: Favipiravir & JT001 Placebo 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 |
Drug: JT001 placebo
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
Other Names:
Drug: Favipiravir
Day 1: 1600mg, Q12H X 1 day; Day 2~5: 600mg, Q12H X 4 days
|
Outcome Measures
Primary Outcome Measures
- progression of COVID-19 [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
Secondary Outcome Measures
- AEs and SAEs [Up to 29 days]
Safety assessments such as AEs and SAEs through Day 29
- Progress, Death [Up to 29 days]
Percentage of participants who experience these events by Day 29 Progress to critical COVID-19 Death from any cause
- WHO 11-point ordinal outcome scale [Day 3, 5, 7, 10 and 29]
The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
- The change of Chest CT scan [Day 7 and 10]
The change of Chest CT scan from baseline to Day 7 and 10（Percentage of lung involved）
- SARS-CoV-2 clearance [Day 3, 5 ,7 and 10]
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Other Outcome Measures
- SARS-CoV-2 viral genetic variation [Day 1]
SARS-CoV-2 viral genetic variation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants of 18 years of age or older, at the time of signing of informed consent
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Participants who have a positive SARS-CoV-2 test result
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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
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Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
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Participants who must agree to adhere to contraception restrictions
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Participants who understand and agree to comply with planned study procedures
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Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
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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
Exclusion Criteria:
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Participants who are judged by the investigator as likely to progress to critical COVID-19 prior to randomization.
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Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
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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
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Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
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Participants who have any of the following conditions when screening:
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ALT or AST>1.5 ULN
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Systolic blood pressure < 90 mm Hg
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Diastolic blood pressure < 60 mm Hg
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Requiring vasopressors
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Multi-organ dysfunction/failure
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Participants who have known allergies to any of the components used in the formulation of the interventions
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Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
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Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
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Participants who have received convalescent COVID-19 plasma treatment
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Participants who have received SARS-CoV-2 vaccine prior to randomization.
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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
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Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
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Female who is pregnant or breast-feeding or plan to be pregnant within this study period
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Male whose wife or partner plan to be pregnant within this study period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Public Health Clinical Center | Shanghai | Shanghai | China | 201508 |
| 2 | Specialized lnfectious Diseases Hospital No2 of Zangiota District | Tashkent | Tashkent Province | Uzbekistan | 1118 |
Sponsors and Collaborators
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor GmbH
Investigators
- Study Director: Juan Ma, Master, Shanghai Junshi Bioscience Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JT001-006-III-COVID-19