Efficacy and Safety of JT001 (VV116) Compared With Favipiravir

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Moderate to Severe COVID-19

Intervention / Treatment
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* Drug: JT001
* Drug: JT001 placebo
* Drug: Favipiravir
* Drug: Favipiravir placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JT001& Favipiravir Placebo<br>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<br>* Day 1: 600mg, Q12H X 1 day; Day 2 5: 300mg, Q12H X 4 days<br>* Other names: VV116;Drug: Favipiravir placebo<br>* Day 1: 1600mg, Q12H X 1 day; Day 2 5: 600mg, Q12H X 4 days<br>|
| Active Comparator: Favipiravir & JT001 Placebo<br>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<br>* Day 1: 600mg, Q12H X 1 day; Day 2 5: 300mg, Q12H X 4 days<br>* Other names: VV116 placebo;Drug: Favipiravir<br>* Day 1: 1600mg, Q12H X 1 day; Day 2 5: 600mg, Q12H X 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and SAEs | Safety assessments such as AEs and SAEs through Day 29 | 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 | 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) | 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） | Day 7 and 10 | 
| SARS-CoV-2 clearance | Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10 | Day 3, 5 ,7 and 10 |