NCT05341609已完成3 期
A Multicenter, Single-blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Paxlovid for the Early Treatment of COVID-19 in Participants With Mild to Moderate COVID-19
Vigonvita Life Sciences7 个研究点 分布在 1 个国家目标入组 822 人开始时间: 2022年4月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 822
- 试验地点
- 7
- 主要终点
- Time to sustained 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) Compared With Paxlovid for the Treatment of Coronavirus Disease 2019 (COVID-19) 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, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures.
Treatment and Assessment Period
This is the general sequence of events during the 28-day treatment and assessment period:
Complete baseline procedures Participants are randomized to an intervention group Participants receive study intervention (Q12H X 5 days), and Complete all safety monitoring
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
- Triple (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 who have a positive SARS-CoV-2 test result.
- •Participants who have one or more mild or moderate COVID-19 symptoms, and total symptom score ≥
- •Participants who have one or more of the following requirements: ≤7 days from the first positive test for SARS-COV-2 virus infection to the first dose; ≤5 days from the first onset of COVID-19 symptoms to the first dose; SARS-CoV-2 Ct Value ≤20 within 24 hours prior to the first dose.
- •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 or legally authorized representatives can give written informed consent approved by the Ethical Review Board governing the site.
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •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.
- •Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation.
- •Participants who have eye disease.
- •Participants who have any of the following conditions when screening: ALT or AST>1.5 ULN; e GFR <60 mL/min.
- •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.
- •Participant's use of contraindicated drugs in the Package Insert of Nirmatrelvir Tablet/Ritonavir Tablets.
- •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.
研究组 & 干预措施
JT001(VV116)
Experimental
Day 1: 600mg, Q12H X 1 day; Day 2~5: 300mg, Q12H X 4 days
干预措施: JT001 (Drug)
Paxlovid
Active Comparator
Day 1~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days
干预措施: Paxlovid (Drug)
结局指标
主要结局
Time to sustained clinical recovery
时间窗: Up to 28 days
Time to sustained clinical recovery up to 28 days.
次要结局
- AEs and SAEs through Day 28(Up to 28 days)
- Percentage of clinical recovery participants(Days 3, 5, 7, 10, 14, 21 and 28)
- The change of COVID-19 symptom scores(Days 3, 5, 7, 10, 14, 21 and 28)
- Percentage of the participants who have progression of COVID-19 though Day 28(Up to 28 days)
- Percentage of participants who experience these events by Day 28(Day 1 to 28 days)
- Percentage of participants with SARS-CoV-2 clearance(Days 3, 5, 7, 10, 14)
- The change of Chest CT scan(Days 7 or 10)
- The change of WHO clinical progression scale(Days 3, 5, 7, 10, 14, 21 and 28)
- Percentage of participants whose "WHO clinical progression scale" reduced at least one level(Days 3, 5, 7, 10, 14, 21 and 28)
- The change of SARS-COV-2 Ct value(Days 3, 5, 7, 10, 14)
- Time to sustained clinical symptom resolution(Up to 28 days)
- Percentage of participants with clinical symptom resolution(Days 3, 5, 7, 10, 14, 21 and 28)
研究者
研究点 (7)
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