NCT05242042终止2 期
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.
Shanghai JunTop Biosciences Co., LTD8 个研究点 分布在 2 个国家目标入组 381 人开始时间: 2022年1月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 381
- 试验地点
- 8
- 主要终点
- progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
研究概览
简要总结
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.
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
- 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
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
- •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
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, 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
- •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
- •Participants who have received convalescent COVID-19 plasma treatment
- •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
- •Female who is pregnant or breast-feeding or plan to be pregnant within this study period
研究组 & 干预措施
Arm 1
Experimental
干预措施: JT001 (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
progression of COVID-19:defined as progress to severe/critical COVID-19 or death from any cause
时间窗: Up to 28 days
1. Percentage of the participants who have progression of COVID-19 2. Time to sustained clinical symptom resolution
次要结局
- Safety assessments(Up to 28 days)
- The plasma concentration(Baseline through Day 5)
- SARS-CoV-2 viral load(Baseline through Day 7)
- Overall participant clinical status(Up to 28 days)
- COVID-19-related hospitalization rate of non-hospitalized participants(Up to 28 days)
- SARS-CoV-2 negative rate through Day7(Baseline through Day 7)
- To assess SARS-CoV-2 viral genetic variation(Day 1)
研究者
研究点 (8)
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