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)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- progression of COVID-19
研究概览
简要总结
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.
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. 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
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
- •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
排除标准
- •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
研究组 & 干预措施
JT001& Favipiravir Placebo
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
干预措施: JT001 (Drug)
JT001& Favipiravir Placebo
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
干预措施: Favipiravir placebo (Drug)
Favipiravir & JT001 Placebo
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
干预措施: JT001 placebo (Drug)
Favipiravir & JT001 Placebo
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
干预措施: Favipiravir (Drug)
结局指标
主要结局
progression of COVID-19
时间窗: Up to 29 days
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
次要结局
- AEs and SAEs(Up to 29 days)
- WHO 11-point ordinal outcome scale(Day 3, 5, 7, 10 and 29)
- SARS-CoV-2 clearance(Day 3, 5 ,7 and 10)
- Progress, Death(Up to 29 days)
- The change of Chest CT scan(Day 7 and 10)