PACTR202210559228718尚未招募3 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 LTD0 个研究点目标入组 1,310 人开始时间: 2022年8月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
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, 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
- •? sore throat
- •? stuffy or running nose,
- •? muscle pain
- •? shortness of breath or difficulty breathing
- •Chills or shivering
- •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:
- •? Are = 60 years of age
- •? Cardiovascular disease (including congenital heart disease and hypertension)
- •? Chronic lung diseases (for example, chronic obstructive pulmonary disease (COPD), asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)
- •? Immunosuppressive disease or immunosuppressive treatment(for example,long-term use of corticosteroids or other immunosuppressive drugs lead to decreased immune function)
- •? Overweight or obesity BMI>25 kg/m2
- •? Sickle cell disease
- •? Active cancer
- •? Chronic kidney disease
- •? Current smoker
- •? Neurodevelopmental disorders (e.g., cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolicsyndromes and severe congenital anomalies)
- •? Need relevant medical support (not related to COVID-19) (such as tracheotomy, gastrostomy or positive pressure ventilation, etc.)
- •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 l
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(with oxygen inhalation), 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 (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion)
- •Participants who have ALT or AST>2 ULN at screening
- •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) within180 days prior to screening visit
- •Participants who have received convalescent COVID-19 plasma treatment within180 days prior to screening visit
- •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
研究者
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