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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,369
- 试验地点
- 9
- 主要终点
- Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) in participants with mild to moderate COVID-19.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •sore throat
- •stuffy or running nose,
- •muscle or body aches
- •shortness of breath or difficulty breathing
- •chills or shivering
- •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.
排除标准
- •Severe or critical COVID-
- •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.
研究组 & 干预措施
Arm 1
JT001 (VV116) Day 1: 0.6g, Q12H X 2 times Day 2-5: 0.3g, Q12H X 8 times Oral tablet
干预措施: JT001 (Drug)
Arm 2
Placebo Day 1: 6 tablets, Q12H X 2 times Day 2-5: 3 tablets, Q12H X 8 times Oral tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Characterize the effect of JT001 (VV116) compared to placebo on clinical recovery
时间窗: Up to 28 days
Time to sustained clinical symptoms resolution
次要结局
- Clinical alleviation(Up to 28 days)
- SARS-CoV-2 nucleic acid and viral load(Up to 28 days)
- Safety(Up to 28 days)
- Disease progression(Up to 28 days)