JT001 (VV116) for the 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 and safety of JT001 (VV116) in participants with mild to moderate 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 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 This is the general sequence of events during the 28-day treatment and assessment period: Complete baseline procedures and samples collection； Participants are randomized to experimental arm or placebo arm； 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 III Clinical Study to Evaluate the Efficacy and Safety of JT001 (VV116) 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, at the time of signing of informed consent. Have a positive SARS-CoV-2 test result, and sample collection for the first positive SARS-CoV-2 viral infection determination ≤5 days prior to the first dose. Note: PCR is the preferred method; however, with evolving approaches to laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed. Initial onset of symptoms of COVID-19 ≤3 days prior to the first dose. Have any of the following targeted COVID-19-related symptoms with COVID-19 Related Symptoms score ≥2 within 24 hours before the first dose: fever cough sore throat stuffy or running nose, headache muscle or body aches shortness of breath or difficulty breathing nausea chills or shivering vomiting diarrhea Agree to adhere to contraception restrictions.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Understand and agree to comply with planned study procedures. 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: Severe or critical COVID-19. SpO2≤93% on room air at sea level or PaO2/FiO2≤ 300 (with oxygen inhalation), or respiratory rate ≥30 per minute, or heart rate ≥125 per minute. Require mechanical ventilation or anticipated impending need for mechanical ventilation. 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. Current eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion). ALT or AST>2 ULN at screening. 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. Received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within 30 days prior to screening. Received convalescent COVID-19 plasma treatment within 30 days prior to screening. Participated in a clinical study involving an investigational intervention within the last 30 days. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Female who are 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>JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet | Drug: JT001<br>* JT001 administered orally in tablet form every 12 hours for 5 days<br>* Other names: VV116;|
| Placebo Comparator: Arm 2<br>Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet | Drug: Placebo<br>* Placebo matching JT001 administered orally in tablet form every 12 hours for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery | Time to sustained clinical symptoms resolution | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical alleviation | Time to sustained clinical symptoms alleviation | Up to 28 days | 
| Disease progression | Percentage of participants who experience the following events of disease progression through Day 28 COVID-19-related hospitalization in non-hospitalized participants Progression to severe COVID-19 Progression to critical COVID-19 Death from any cause | Up to 28 days | 
| SARS-CoV-2 nucleic acid and viral load | Percentage of participants who achieve SARS-CoV-2 negative through Days 5 and 7 Change of SARS-CoV-2 Ct Value from baseline to Days 5 and 7 Change of SARS-CoV-2 viral load from baseline to Days 5 and 7 SARS-CoV-2 viral load area under the response time curve (AUC) assessed through Day 7 | Up to 28 days | 
| Safety | Safety assessments such as AEs and SAEs through Day 28 | Up to 28 days |