NCT06142201进行中（未招募）不适用
A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)
Shanghai Vinnerna Biosciences Co., Ltd.6 个研究点 分布在 1 个国家目标入组 7,656 人开始时间: 2023年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,656
- 试验地点
- 6
- 主要终点
- Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
研究概览
简要总结
Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Age ≥18 years old.
- •The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:
- •Diagnosis of novel coronavirus infection; 2) Diagnosed with novel coronavirus pneumonia; 3) The novel coronavirus nucleic acid test is positive; 4) Test positive for novel coronavirus antigen; 5) Culture positive for novel coronavirus.
- •Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression.
排除标准
- •· Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or those who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: Nematavir tablet/Ritonavir tablet, Azvudine tablet, Monoravir capsule, Zenotavir tablet/Ritonavir tablet, Leritvir tablet, Ambavirzumab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for COVID-19 survivors.
研究组 & 干预措施
No anti-SARS-CoV-2 treatment
干预措施: JT001 (Drug)
JT001
干预措施: JT001 (Drug)
结局指标
主要结局
Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28
时间窗: Within 28 days
Incidence of COVID-19 disease progression (severe COVID-19 or death from any cause) at day 28 from COVID-19 diagnosis. According to the diagnosis of severe COVID-19 and indicators meeting the diagnostic definition of severe COVID-19, the evaluation and analysis were performed.
次要结局
- The incidence of all aes and abnormal laboratory changes on day 28, etc(Within 28 days)
- Incidence of the following COVID-19 disease progression events by day 28(Within 28 days)
- Incidence of severe Covid-19-related events up to day 28(Within 28 days)
研究者
研究点 (6)
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