Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
NCT ID: NCT05279235
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
290 participants
INTERVENTIONAL
2022-03-14
2022-12-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
JT001
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
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
JT001 placebo
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Favipiravir
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Interventions
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JT001
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
JT001 placebo
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Favipiravir
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Favipiravir placebo
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who have a positive SARS-CoV-2 test result
3. 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
4. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300
5. Participants who must agree to adhere to contraception restrictions
6. Participants who understand and agree to comply with planned study procedures
7. Participants or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site
8. 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
2. Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation
3. 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
4. Participants who have eye disease (such as inflammation, Vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
5. Participants who have any of the following conditions when screening:
* ALT or AST\>1.5 ULN
* Systolic blood pressure \< 90 mm Hg
* Diastolic blood pressure \< 60 mm Hg
* Requiring vasopressors
* Multi-organ dysfunction/failure
6. Participants who have known allergies to any of the components used in the formulation of the interventions
7. Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant
8. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment)
9. Participants who have received convalescent COVID-19 plasma treatment
10. Participants who have received SARS-CoV-2 vaccine prior to randomization.
11. 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
12. Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
13. Female who is pregnant or breast-feeding or plan to be pregnant within this study period
14. Male whose wife or partner plan to be pregnant within this study period
18 Years
ALL
No
Sponsors
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Sponsor GmbH
OTHER
Shanghai Vinnerna Biosciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Ma, Master
Role: STUDY_DIRECTOR
Shanghai Junshi Bioscience Co., Ltd.
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Specialized lnfectious Diseases Hospital No2 of Zangiota District
Tashkent, Tashkent Region, Uzbekistan
Countries
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Other Identifiers
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JT001-006-III-COVID-19
Identifier Type: -
Identifier Source: org_study_id
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