JT001 (VV116) for the Early Treatment of COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of JT001 (VV116) for the early Treatment of Coronavirus Disease 2019 (COVID-19) in participants with mild to moderate COVID-19, at high risk for progression to severe COVID-19, including death.

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 Complete baseline procedures and sample collection Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days) Complete all safety monitoring Complete all efficacy data collection Blood samples collection

Official Title
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A Multicenter, Double-blind, Randomized, Placebo-Controlled, Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of JT001 (VV116) for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Participants With Mild to Moderate COVID-19.

Conditions
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Mild to Moderate COVID-19

Intervention / Treatment
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* Drug: JT001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants of 18 years of age or older Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination ≤5 days prior to randomization Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score ≥3 Participants with the onset of symptoms of COVID-19 ≤5 days prior to randomization Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: Participants who must agree to adhere to contraception restrictions Participants who understand and agree to comply with planned study procedures Participants can give written informed consent approved by the Ethical Review Board governing the site and comply 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 severe/critical COVID-19 prior to randomization. Participants who have SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300, or respiratory rate ≥30 per minute, or heart rate ≥125 per minute 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 Participants who have ALT or AST>2 ULN at screening 7 Participants who have known allergies to any of the components used in the formulation of the interventions 8 Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant 9. Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 180 days prior to screening visit 10. Participants who have received convalescent COVID-19 plasma treatment 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

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: Arm 1<br> | Drug: JT001<br>* JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)<br>* Other names: VV116;|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days (10 doses total)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause | Percentage of the participants who have progression of COVID-19 Time to sustained clinical symptom resolution | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall participant clinical status | Percentage of participants who experience these events by Day 28 Progress to severe COVID-19 Progress to critical COVID-19 Death from any cause | Up to 28 days | 
| COVID-19-related hospitalization rate of non-hospitalized participants | Percentage of participants who experience COVID-19-related hospitalization by Day 28 | Up to 28 days | 
| SARS-CoV-2 negative rate through Day7 | Percentage of participants who achieve SARS-CoV-2 negative at Day 5 and 7 | Baseline through Day 7 | 
| The plasma concentration | The plasma concentration of JT001 (VV116) and major metabolites | Baseline through Day 5 | 
| Safety assessments | Safety assessments such as AEs and SAEs | Up to 28 days | 
| SARS-CoV-2 viral load | The SARS-CoV-2 viral load change from baseline to Day 5 and 7 | Baseline through Day 7 | 
| SARS-CoV-2 viral load | SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7 | Baseline through Day 7 | 
| To assess SARS-CoV-2 viral genetic variation | SARS-CoV-2 viral genetic variation | Day 1 |